The adjunctive effect of a qigong (Baduanjin) intervention program on maternal and child health outcomes: a multicenter randomized controlled trial protocol

Abstract

Introduction

Lifestyle interventions are critical for optimizing maternal and child health outcomes during pregnancy. As a mind-body exercise rooted in the principles of traditional Chinese Medicine (TCM), qigong shows promise as adaptable prenatal interventions, but the evidence is limited.

Objective

This multicenter randomized controlled trial (RCT) protocol aims to evaluate the additive effect of a qigong intervention program, compared to routine lifestyle intervention alone, on reducing the rate of caesarean section (primary outcome) and improving a range of secondary maternal and child health outcomes.

Methods

This multicenter RCT will be conducted across 11 institutions in China. A total of 1062 participants aged 18–45 years, with singleton pregnancies at 11–13^+ 6 weeks of gestation, will be enrolled and randomly allocated to two groups using a central stratified block randomization method. Participants will be randomized to either a control group receiving standard prenatal care plus evidence-based lifestyle education (encompassing nutrition, physical activity, sleep hygiene, stress management, and environmental avoidance), or an intervention group receiving all control components supplemented with supervised pregnancy-adapted qigong intervention (a modified seated Baduanjin exercise program). The primary outcome is caesarean section rate. Secondary outcomes include obstetric complications (abortion, preterm birth, gestational diabetes mellitus, gestational hypertension, postpartum hemorrhage, fetal growth restriction), neonatal indicators (birth weight, Apgar scores), maternal gestational weight gain, and mental health and sleep-related outcomes assessed through validated instruments such as Perceived Stress Scale-4 (PSS-4) for stress levels, Fear of Birth Scale (FOBS) for fear of childbirth, and Brief Pittsburgh Sleep Quality Index (B-PSQI) for sleep quality.

Conclusion

This rigorously designed multicenter RCT protocol addresses a significant gap by investigating whether integrating the traditional mind-body practice of qigong into standard prenatal lifestyle education confers additional benefits for reducing cesarean sections and enhancing broader maternal-child health metrics. The findings will provide robust evidence on the clinical value of this TCM intervention in integrative prenatal care to improve pregnancy outcomes and maternal and child well-being.

Trial registration

This trial was registered at International Traditional Medicine Clinical Trial Registry, ITMCTR2025002612.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12884-026-08714-0.

Introduction

Pregnancy represents a critical period where maternal lifestyle choices exert profound and lasting impacts on both maternal well-being and neonatal health outcomes. Comprehensive lifestyle interventions, encompassing balanced nutrition, appropriate physical activity, adequate sleep, stress management, and avoidance of harmful exposures, are widely recognized as cornerstone strategies for optimizing pregnancy outcomes and reducing associated complications [1–3]. Such interventions demonstrably contribute to lowering risks of gestational diabetes mellitus (GDM), hypertensive disorders of pregnancy (HDP), excessive gestational weight gain (GWG), preterm birth, and caesarean Sects [4–8].

Despite established guidelines promoting healthy lifestyles during pregnancy [9, 10] , the global caesarean section rate continues to rise significantly, often exceeding medically necessary levels and raising concerns about associated maternal and neonatal morbidities [11, 12]. This trend underscores the urgent need for more effective, accessible, and acceptable strategies to support pregnant women in achieving optimal health behaviors and reducing avoidable cesarean sections. While conventional lifestyle counseling programs form the basis of prenatal care, there is growing interest in exploring complementary and integrative approaches that may enhance adherence, address psychological well-being holistically, and provide additional benefits.

Traditional Chinese Medicine (TCM) offers a rich repository of qigong practices, among which Baduanjin (Eight-Section Brocade) stands out as a particularly suitable candidate for prenatal application. Baduanjin, characterized by gentle, flowing movements, coordinated deep breathing, and meditative focus, emphasizes the integration of body, breath, and mind, nurturing both physical form and spirit [13, 14]. Its low-impact nature and emphasis on breath regulation make it especially safe for pregnant women. Preliminary evidence suggests that Baduanjin practice may improve psychological well-being (reducing anxiety, depression, and stress), enhance sleep quality, and promote better glycemic control [12–16]. These effects align closely with key factors influencing pregnancy outcomes and birth experiences.

Nevertheless, critical gaps persist in the current evidence base. There is a paucity of robust research evaluating its additive value when integrated into a comprehensive, evidence-based prenatal lifestyle intervention program. Specifically, it remains unclear whether supplementing established multi-component lifestyle counseling with structured qigong practice confers significant additional benefits, particularly concerning the pivotal outcome of caesarean section rate. Furthermore, comprehensive assessments simultaneously evaluating a broad spectrum of maternal and neonatal outcomes within this context are lacking.

Affecting 6%–20% women of reproductive age worldwide [17], polycystic ovary syndrome (PCOS) is characterized by endocrine and metabolic disturbances, posing a significant threat to maternal and child health during pregnancy. Women with PCOS exhibit notably higher risk of the most common gestational complications, including GDM, HDP, preterm delivery and fetal growth restriction (FGR), contributing to the rising of caesarean section rate [18, 19]. In addition, women with PCOS are markedly more prone to anxiety and depression linked to poorer health-related quality of life [20]. Psychological stress can exacerbate insulin resistance and hyperandrogenemia, creating a vicious cycle that worsens the underlying endocrine-metabolic disorder and further deteriorates pregnancy outcomes [21, 22]. Including a predefined PCOS subgroup will allow the trial to assess whether mind-body practice qigong confers specific advantages for this high-risk population.

Therefore, this protocol describes the design of a multicenter randomized controlled trial (RCT) specifically designed to address these above significant knowledge gap. The primary objective is to determine the additive effect of a qigong exercise, delivered alongside a comprehensive prenatal lifestyle intervention course, on reducing the incidence of caesarean section compared to the routine lifestyle intervention alone. Secondary objectives encompass evaluating the additive effect of a qigong intervention on a wide array of critical maternal and neonatal health indicators, including obstetric complications (abortion, preterm birth, GDM, HDP, postpartum hemorrhage, fetal growth restriction), neonatal indicators (birth weight and Apgar scores), maternal gestational weight gain, and maternal psychological state (stress, fear of childbirth, and sleep quality).

This rigorously designed trial aims to generate high-level evidence on the specific contribution of this culturally resonant, low-risk TCM mind-body practice within a modern prenatal care framework. Findings have the potential to inform the development of more effective and integrative strategies for promoting maternal and child health and optimizing pregnancy outcomes globally.

Methods

Objective

This study aims to evaluate the additive effect of a qigong exercise, compared to routine lifestyle intervention alone, on reducing the rate of caesarean section (primary outcome) and improving secondary outcomes of maternal and child health. The participant progression and overall design of this randomized controlled trial are illustrated in Fig. 1.

Fig. 1.

Flow chart of study procedures

Study design

This study employs an assessor-blinded, parallel-group, multicenter RCT design with two arms. Ethical approval will be obtained from the Institutional Review Board (IRB) or Ethics Committee of each participating center prior to commencement. The trial has been registered on Chinese Clinical Trial Registry before participant enrollment begins. It adheres to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for RCTs and the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) checklist.

Eligibility and recruitment

The study will be undertaken at 11 clinical centers in China: Women’s Hospital, School of Medicine, Zhejiang University; The First Affiliated Hospital of Army Medical University; Xiamen Maternal and Child Health Hospital; Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University; Fujian Maternal and Child Health Hospital; Maternal and Child Health Affiliated Hospital of Nanchang University; Maternal and Child Health Hospital of Inner Mongolia Autonomous Region; Dalian Women and Children’s Medical Center (group); Aksu Prefecture Maternal and Child Health Hospital; Linhai Branch, Women’s Hospital, School of Medicine, Zhejiang University (Linhai Maternal and Child Health Hospital); Dongguan Maternal and Child Health Hospital. Potentially eligible women will be identified during first prenatal visits. Trained obstetricians will screen medical records, explain the study, and obtain written consent. Recruitment targets are stratified by site based on annual delivery volumes.

Inclusion criteria

The inclusion criteria are: nulliparous woman with a singleton pregnancy; 18–45 years of age; ≤13⁺⁶ weeks’ gestation, and gestational age was estimated according to the participant’s report of her last menstrual period (LMP) date, or recalculated by crown-rump length at the scan of translucency thickness if the LMP was obscure or there was an obvious discordance between the ultrasonographic measurement and LMP dating (> 7 days); ability to communicate well with the researcher and comply with the test requirements; and provision of written informed consent. In addition to the original inclusion criteria, participants will be defined as PCOS prior to pregnancy, based on the 2003 Rotterdam Criteria [23]. Presence of at least two of the following three features: oligo-ovulation or anovulation (documented by menstrual irregularity); clinical or biochemical hyperandrogenism; polycystic ovarian morphology (PCOM) on transvaginal ultrasound before pregnancy.

Exclusion criteria

The exclusion criteria are: have participated in qigong training or other mind-body interventions within the previous 6 months; known chromosomal or genetic abnormalities in either parents or the fetus; pre-existing medical conditions including severe endocrine disorders (including diabetes mellitus requiring medication), severe cardiovascular disease (including chronic hypertension requiring medication), severe renal or hepatic impairment, active autoimmune disease requiring immunosuppression, or malignancy; history of major psychiatric disorders requiring ongoing treatment or posing significant risk; absolute contraindications to exercise; current signs/symptoms of threatened abortion or undergoing treatment for threatened abortion; history of cervical incompetence or cerclage in the current pregnancy, other conditions contraindicating physical activity or vaginal delivery; long-term use during pregnancy of medications known to significantly impact glucose metabolism or body weight; planned relocation outside the study catchment area before the completion of follow-up assessments; no regular stress reduction practice with a mindfulness component (including meditation or yoga more than twice a week); and any other condition deemed by the investigator to make participation unsafe or adherence unlikely.

Withdrawal criteria

The withdrawal criteria are: adverse events (AEs) related to interventions occur such as severe psychological distress, exercise-related complications; protocol deviations such as non-compliance > 50% of sessions (verified by records) and use of excluded therapies/interventions during the study period (without prior approval from the research team); and participant-initiated withdrawal. In addition, participants may withdraw voluntarily at any time, with the reasons documented to assess potential bias.

Dropout criteria

The dropout criteria are: geographic relocation outside the study area resulting in inability to track outcomes; and loss to follow-up.

Randomization and blinding

Participants will be allocated 1:1 to either a usual care control group receiving standard prenatal care plus evidence-based lifestyle education, or an intervention group receiving all control components supplemented with a supervised pregnancy-adapted qigong exercise. The random allocation sequence will be generated by an independent statistician using conventional statistical computer software (SPSS V.25.0), adopting a stratified block randomization method with stratification factors including age, enrollment BMI, PCOS status, and study center and a block size of 4. A unique random seed (20251101) will be set during sequence generation for reproducibility.

Due to the inherent nature of the exercise-based intervention, it is not feasible to blind participants or the instructors delivering the qigong sessions to group assignment. However, comprehensive blinding procedures will be rigorously implemented for key research personnel to minimize ascertainment and analytical bias. Outcome assessors responsible for collecting postpartum data, including verification of caesarean section, obstetric complications, neonatal outcomes, and medical record abstraction, will be blinded to group allocation throughout the trial. Similarly, personnel administering questionnaires will be unaware of treatment assignment. Crucially, the two independent obstetricians verifying caesarean section events will be blinded to prenatal study participation and will base their assessments solely on delivery medical records. Furthermore, data analysts and statisticians conducting primary and secondary analyses will work with de-identified datasets where groups are coded neutrally (e.g., Group A/Group B). Emergency unblinding will be strictly limited to situations requiring critical clinical management of severe adverse events and must be approved by the site principal investigator, with all instances formally documented.

Interventions

All participants will receive standardized routine prenatal care including an initial prenatal visit between 11⁺⁰ to 13⁺⁶ weeks’ gestation and subsequent routine prenatal visits for monitoring maternal and fetal well-being. Additionally, all participants will also participate in periodic structured health education courses covering evidence-based recommendations on prenatal health, safe physical activity, sleep hygiene, stress management, emotional well-being and avoidance of harmful exposures (Table 1). Participants randomized to the control group will receive this combined standard care and health education program. Participants randomized to the intervention group will receive identical standard care and health education, with the addition of a qigong (modified seated Baduanjin) exercise program specifically adapted for pregnancy safety that will be initiated at 14 weeks’ gestation and continued until the day of delivery. Key modifications to the traditional Baduanjin protocol are made to avoid increasing abdominal pressure, a critical safety concern during pregnancy, and these modifications include the exclusion of two classic movements including ‘Holding the Feet to Strengthen the Kidneys’, which involves forward bending that may cause potential abdominal compression, and ‘Shaking the Head and Swinging the Tail to Relieve Fire’, which includes dynamic torso movements that could strain the abdominal area. Beyond the exclusion of these two movements, additional safety adjustments are integrated to align with prenatal physical needs, such as avoidance of deep squats, jumps, prolonged supine positions, and excessive stretching, all of which could pose risks to maternal and fetal well-being. The modified seated Baduanjin program will be delivered following a standardized protocol comprising a group-learning phase (one 1-hour guided qigong exercise training session per week for 4 consecutive weeks, which is designed to ensure participants master the correct form of the modified seated movements) and a self-practice phase requires each participant to complete the exercise independently throughout the entire intervention period. It will be recommended that participants practice on 5–7 days per week, finish 1–3 full qigong sessions each practice day, and each single session will last approximately 9 minutes. To minimize participant attrition, researchers involved in this RCT will maintain regular one-on-one contact with all participants, providing routine follow-up support to address general pregnancy-related concerns. Additionally, the intervention group will receive targeted support to resolve challenges related to the qigong exercise.

Table 1.

Overview of core sessions: Evidence-Based lifestyle education

Session Title	Topic
1. Prenatal Health Basics	- Physiological changes in pregnancy - Prenatal care schedule - Warning signs of complications
2. Safe Physical Activity in Pregnancy	- Types of safe exercises during pregnancy - Intensity guidelines - Contraindicated activities
3. Prenatal Healthy Eating Guidelines	- Core nutritional needs during pregnancy - Meal frequency and portion control - Food safety precautions - Managing pregnancy-specific dietary challenges - Hydration recommendations
4. Sleep Hygiene for Pregnant Women	- Optimal sleep positions - Sleep duration recommendations - Strategies for better sleep
5. Stress Management Techniques	- Sources of stress in pregnancy - Coping and relaxation skills
6. Emotional Well-being in Pregnancy	- Identifying emotional changes - Building social support - Coping with mood fluctuations
7. Avoidance of Harmful Exposures	- Teratogenic substances (medications, chemicals) - Environmental hazards - Infectious risks

To ensure intervention fidelity and result interpretability, compliance will be systematically assessed for all participants. For the intervention group, compliance with qigong is evaluated via daily self-reported logs (recording practice frequency, duration, barriers) and monthly follow-up verbal confirmation, defined as completing ≥ 80% of the program. For the control group, compliance with education content is assessed via self-reported checklists, defined as adhering to ≥ 70% of key recommendations (Table 1). Reasons for non-compliance such as physical discomfort and time constraints will be documented.

Outcome measures

Primary outcome

The primary outcome is caesarean section rate, defined as the proportion of participants undergoing cesarean section (selective or emergency). Clinical decisions for cesarean section will be made by attending obstetricians per standard indications and guidelines. The outcome of caesarean section will be verified by two independent obstetricians blinded to group allocation, and the delivery records will be extracted from electronic health record (EHR) system.

Secondary outcomes

Secondary outcomes encompass obstetric complications, maternal gestational weight gain and psychological measures as well as neonatal indicators. Obstetric complications include GDM diagnosed via a 75 g oral glucose tolerance test (OGTT) based on the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria [24] and the Guidelines for the Diagnosis and Management of Gestational Diabetes Mellitus (2022) (Chinese Society of Obstetrics and Gynecology, CSOG) [25], HDP diagnosed per the International Society for the Study of Hypertension in Pregnancy (ISSHP) recommendations and the Guidelines for the Diagnosis and Management of Hypertensive Disorders in Pregnancy (2020) (CSOG) [26, 27], preterm delivery (< 37 weeks’ gestation) [28], miscarriage (< 28 weeks’ gestation) [29], FGR diagnosed per American College of Obstetricians and Gynecologists (ACOG) 2019 guideline [30] and postpartum hemorrhage (PPH, blood loss: ≥ 500mL within 24 h after vaginal delivery, or ≥ 1000 mL after caesarean section) [31]. Maternal gestational weight gain (GWG) refers to total kilograms from enrollment to delivery. Neonatal indicators including birth weight (grams), and Apgar scores at 1 and 5 min [32, 33]. And psychological measures and sleep-related outcomes assessed through validated instruments such as Perceived Stress Scale-4 (PSS-4) for stress levels [34–36], Fear of Birth Scale (FOBS) for fear of childbirth [37–39], and Brief Pittsburgh Sleep Quality Index (B-PSQI) for sleep quality [40, 41].

Data collection

Data will be collected from the EHR system by trained research staff (blinded to randomization assignment) in the medical centers where women receive their usual care, with additional relevant data gathered through an online questionnaire. Trained research staff based at the Division of Research will oversee data quality and management. Data collection will be conducted from March 2026 to March 2028.

Baseline data collection

Baseline data collection will occur at enrollment and include comprehensive assessment of demographic characteristics (age, occupation, educational attainment), obstetric history (gravidity, parity, prior pregnancy outcomes), metabolic parameters (enrollment weight, height for BMI calculation), environmental exposures (tobacco/alcohol/caffeine exposure), baseline psychological health and sleep related status (PSS-4, FOBS, and B-PSQI). For participants in the PCOS subgroup, additional information will be obtained to assess hyperandrogenic manifestations [42, 43].

Follow-up assessments

Firstly, capture late-pregnancy outcomes including obstetric complications, interim weight gain, psychological and sleep status (PSS-4, FOBS, and B-PSQI), and fetal growth metrics via fetal biometry. Secondly, delivery outcomes, including mode of delivery, postpartum hemorrhage, neonatal birth weight, and Apgar scores, will be extracted within 72 h of delivery from standardized medical records.

For participants in the PCOS subgroup, additional information will be collected to assess hyperandrogenic manifestations.

Statistical methods

Independent analysts will conduct statistical analysis using SPSS V.25.0. All analyses will be undertaken using the intention-to-treat (ITT) approach, additionally, a per-protocol (PP) analysis will be performed as sensitivity analysis, with PP population defined as those who completed assigned interventions with adequate compliance (≥ 80% qigong sessions for intervention group, ≥ 70% lifestyle adherence for control group), no major protocol deviations, and complete primary outcome data.

For continuous data, t-tests, covariance analysis (adjusting for baseline covariates like age, enrollment BMI, PCOS status, study center) or Wilcoxon-Mann-Whitney tests will be used for analysis. Linear regression (adjusting for the same covariates) will analyze intervention-continuous outcome associations. For categorical data, χ² tests or Fisher’s exact tests will be used. In addition, a logistic regression analysis (adjusting for above covariates) will be undertaken to determine associations between the intervention arm and the outcomes.

For the exploratory PCOS subgroup, stratified analyses by PCOS status will be conducted for key outcomes, and PCOS status will be included as a covariate in regression models. Given the small projected sample size (approximately 106), this analysis focuses on effect trends.

Missing outcome data will be handled via multiple imputation (MAR assumption, 5 imputed datasets) with baseline covariates and observed data, complete-case analysis will be an additional sensitivity analysis, and missing data proportions will be documented.

Ethics and dissemination

The study has been approved by the ethics committee of Women’s Hospital, School of Medicine, Zhejiang University (No. IRB-20250451-R). Any modifications to the protocol will be submitted for ethics approval and updated in the ITMCTR. All participants will receive a comprehensive explanation of the purpose, procedures and potential risks associated with the trial and will be required to provide informed consent before taking part. The data obtained in the study will be made available by the corresponding author on reasonable request. The results will be published in international scientific journals.

Power and sample size

The sample size calculation targeted a clinically meaningful 25% relative risk reduction (RRR) in caesarean section rates for the intervention group, corresponding to an absolute decrease from the anticipated control group rate of 35% to 26.25%. This effect magnitude falls within the high end of efficacy estimates reported for structured prenatal mind-body interventions, as supported by meta-analytic or RCT evidence [44–48]. Based on standard statistical parameters (two-sided α = 0.05, statistical power = 80%), the initial calculation determined a minimum requirement of 435 participants per group for detecting this difference in proportions. Allowing for a small rate of attrition, accommodate between-center variability across the 11 recruitment sites and enable prespecified subgroup analyses, the sample size was increased to 531 per group.

Based on previous epidemiological data, PCOS is estimated to affect approximately 10% of the total study population (n = 1062), resulting in a projected subgroup sample size of approximately 106 participants (approximately 53 in the intervention group and 53 in the control group). Due to the small sample size of this subgroup, statistical power will be limited. This analysis is explicitly defined as exploratory rather than confirmatory. The purpose is to preliminarily explore potential effect trends of the intervention in the PCOS population, rather than verifying definitive effectiveness hypotheses.

Discussion

This multicenter RCT protocol addresses a critical evidence gap regarding the integrative potential of traditional Chinese mind-body exercises within contemporary prenatal care frameworks. Despite robust evidence supporting lifestyle interventions for optimizing pregnancy outcomes, the persistently high global caesarean section rates underscore the limitations of conventional approaches and the urgent need for innovative strategies. Qigong Baduanjin, with its dual emphasis on physical movement and mental regulation, represents a culturally resonant, low-risk intervention theoretically aligned with the biopsychosocial model of perinatal health [13, 14]. However, existing studies have primarily evaluated Baduanjin as a standalone therapy or against passive controls, failing to isolate its additive value when integrated into comprehensive prenatal lifestyle programs [49–51], a knowledge gap with significant implications for clinical translation.

Since 1985, the World Health Organization (WHO) has clearly stated that the ideal range for caesarean section rates is 10%–15%, rates above this range have not produced systematic improvements in maternal or neonatal outcomes [52, 53]. However, the alarming global escalation in caesarean section rates has evolved into a pressing public health crisis, with China epitomizing this concerning trajectory as rates surged from 28.8% in 2008 to 34.9% by 2014 [54–56]. This upward trend persisted in China, as data from 2020 revealed that for overall and low-risk deliveries, the mean caesarean section rates stood at 44.5% and 40.0%, respectively, both substantially higher than the internationally recognized ideal range [57, 58]. And in 2022, the overall caesarean section rate in China reached 45.0%, and notably, the rate among primiparas hit 43.59%, indicating that this key indicator has been gradually climbing in recent years [59]. This phenomenon stems from a complex interplay of patient anxieties including fear of labor pain, misconceptions regarding neonatal safety with vaginal delivery, and cultural preferences for auspicious birth dates, systemic constraints such as midwifery shortages, high delivery volumes favoring scheduled procedures, and inadequate training in physiologic birth, and perverse financial incentives that may inadvertently prioritize surgical over physiologic birth [60–63]. Non-medically indicated caesarean section unequivocally elevates maternal risks (placental disorders, uterine rupture) and neonatal complications while imposing substantial long-term economic burdens [64–66]. These consequences crystallize with particular urgency in China’s three-child policy, where multiparous women with prior cesareans face compounded risks of scarred uteri and placenta accreta spectrum disorders, perpetuating cycles of repeat surgical deliveries [67, 68].

Baduanjin, as a low intensity mind-body exercise, has accumulated evidence indicating its capacity to improve both psychological and metabolic outcomes that are directly relevant to reducing unnecessary caesarean deliveries. Randomized trials have shown that a 12-week Baduanjin program significantly lowered depressive symptom scores while concurrently reducing fasting blood glucose and HbA1c in patients with comorbid depression and type 2 diabetes [69]. Beyond glucose regulation, Baduanjin has been demonstrated to enhance antioxidant capacity, as evidenced by increased superoxide dismutase activity and decreased malondialdehyde levels after a 12-week intervention, suggesting a mechanistic link to reduced oxidative stress related insulin resistance [70]. For women exposed to intimate partner violence (IPV), a group prone to psychological distress, sleep disorders, and subsequent pregnancy complications, a 22-week Baduanjin program improves sleep disorders, with depressive symptoms, perceived stress, and inflammation identified as key pathways for this effect [15]. The same 22-week intervention also increases telomerase activity and enhances mental health outcomes in IPV-affected women, addressing both psychological and cellular-level stressors [14]. A 12-week Baduanjin plan improves sleep quality [71], this is relevant to addressing pregnancy-related sleep disturbances. Collectively, these findings confirm that Baduanjin targets multiple psychological, metabolic, and physiological risk factors associated with unnecessary caesarean deliveries across varied populations, supporting its potential as an accessible intervention for reducing caesarean rates with further investigation in obstetric groups.

Within this critical context, our study advances the field by comparing standard prenatal care plus evidence-based lifestyle education against the same active comparator augmented with a modified qigong program. This approach transcends conventional efficacy testing to evaluate the incremental value of integrating this traditional modality into real-world care frameworks. It directly addresses scalability: should the intervention demonstrate clinically meaningful reductions in caesarean section rate (primary outcome) and parallel improvements in maternal-infant health metrics such as gestational diabetes incidence and psychological well-being, it would provide actionable evidence for standardizing qigong within prenatal education protocols. The multicenter recruitment strategy (11 geographically diverse sites) enhances ecological validity across heterogeneous healthcare settings, while stratified randomization (by center, maternal age, and BMI) controls for key confounders affecting obstetric outcomes.

Methodologically, this protocol safeguards outcome validity through three interlocking strategies. Firstly, blinded adjudication of the primary outcome (caesarean section rate) by independent obstetricians minimizes ascertainment bias. Secondly, repeated psychological assessments using validated scales capture dynamic trajectories of maternal well-being across gestational timepoints. And finally, ITT analysis preserves randomization integrity despite anticipated attrition. The target sample size of 1062 participants provides > 80% statistical power to detect a clinically conservative 25% relative risk reduction in caesarean section rates, while inherently accommodating heterogeneity across the multicenter recruitment framework through stratified randomization and preplanned sensitivity analyses.

Potential limitations warrant consideration. First, participant blinding is infeasible given the behavioral nature of Baduanjin, though assessor and analyst blinding mitigate performance bias. Second, the exclusion of high-risk pregnancies (e.g., multiples, pre-existing diabetes) may limit applicability to broader populations; future pragmatic trials could explore adaptations for these groups. Third, while the 10% attrition buffer accounts for pregnancy loss, regional variations in dropout rates may necessitate site-specific retention strategies. Additionally, our planned exploratory analysis of the PCOS subgroup will be limited by the projected small sample size. This constraint reduces statistical power to detect true effects, and findings from this subgroup should therefore be interpreted as hypothesis-generating rather than definitive, with confirmation required in larger, PCOS-specific studies.

In conclusion, this rigorously designed protocol evaluates a scalable prenatal care enhancement model through the integration of evidence-based lifestyle education with traditional mind-body exercise. If the intervention proves successful, its findings will equip clinicians with a low-cost, culturally congruent tool to reduce cesarean sections and optimize perinatal health outcome. To accelerate translational impact, results will be disseminated via peer-reviewed publications, stakeholder workshops, clinical guideline submissions, and open-access protocol registration, ensuring timely adoption into routine prenatal care systems.

Abbreviations

RCT

Randomized controlled trial

TCM

Traditional Chinese medicine

PSS-4

Perceived Stress Scale-4

FOBS

Fear of Birth Scale

B-PSQI

Brief Pittsburgh Sleep Quality Index

GDM

Gestational diabetes mellitus

HDP

Hypertensive disorders of pregnancy

GWG

Gestational weight gain

PCOS

Polycystic ovary syndrome

FGR

Fetal growth restriction

IRB

Institutional Review Board

CONSORT

Consolidated Standards of Reporting Trials

SPIRIT

Standard Protocol Items Recommendations for Interventional Trials

LMP

Last menstrual period

PCOM

Polycystic ovarian morphology

AEs

Adverse events

BMI

Body mass index

EHR

Electronic health record

OGTT

Oral glucose tolerance test

IADPSG

International Association of Diabetes and Pregnancy Study Groups

CSOG

Chinese Society of Obstetrics and Gynecology

ISSHP

International Society for the Study of Hypertension in Pregnancy

ACOG

American College of Obstetricians and Gynecologists

PPH

Postpartum hemorrhage

ITT

Intention-to-treat

PP

Per-protocol

ITMCTR

International Traditional Medicine Clinical Trial Registry

RRR

Relative risk reduction

WHO

World Health Organization

IPV

Intimate partner violence

Authors’ contributions

F.Q., F.X. and D.X. conceived and formulated the trial, reviewed and revised the manuscript. F.W. and W.Z. wrote the manuscript. T.Z., F.Y., X.L., Y.L., H.L., Y.H., D.Y., S.G., X.L.,C.H., J.Z., L.F., L.M. and G.Y. contributed to the revision of the manuscript. All authors read and approved the final manuscript. F.Q. is the guarantor.

Patient and public involvement

Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Funding

This study was supported by National Key R&D Program of China (Grant no.2024YFC3505800 to F.W), National Natural Science Foundation of China (Grant no.82575119 to F.Q., Grant no.81873837 to F.W) and Zhejiang Traditional Chinese Medicine Multidisciplinary Innovation Team.

The funding bodies had no role in the study design or writing of this manuscript.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

This research protocol has been approved by the ethics committee of Women’s Hospital, School of Medicine, Zhejiang University (No. IRB-20250451-R) and registered in the International Traditional Medicine Clinical Trial Registry, ITMCTR2025002612.

Consent for publication

All participants will sign the Informed Consent Form, with authorization for deidentified data sharing.

Competing interests

The authors declare no competing interests.