Table 3.
Secondary outcomes of pregnancy complications, delivery events, and neonatal outcomes with the NiPPeR intervention compared with control
| Control | Intervention | Effect of intervention | |
|---|---|---|---|
| Pregnancy complications | RR (95% CI)† | ||
| GDM* (denominator: all those who completed OGTT at 24–32 weeks) | 64/283 (22.6) | 73/294 (24.8) | 1.22 (0.92–1.62) (n = 545) |
| Miscarriages <24 weeks gestation (denominator: all those who became pregnant after the second preconception visit) | 51/359 (14.2) | 50/366 (13.7) | 0.91 (0.62–1.33) (n = 688) |
| Congenital abnormalities‡ (denominator: all reaching 7 weeks) | 16/314 (5.1) | 15/330 (4.5) | 0.83 (0.35–1.96) (n = 557) |
| Severe nausea and vomiting of pregnancy§ (denominator: all reaching 7 weeks) | 51/305 (16.7) | 43/322 (13.4) | 0.86 (0.57–1.30) (n = 553) |
| Hypertensive disorders of pregnancy, both preeclampsia‖ and pregnancy-induced hypertension¶ (denominator: all pregnancies reaching ≥24 weeks) | 14/292 (4.8) | 12/294 (4.1) | 1.19 (0.55–2.59) (n = 557) |
| Delivery outcomes (denominator: all live births ≥24 weeks unless otherwise stated) | Mean difference (95% CI)# or RR (95% CI)# | ||
| Gestational age at birth in decimal weeks | 39.2 (1.74) | 39.3 (1.78) | 0.20 (−0.06 to 0.46) (n = 553) |
| All preterm deliveries (<37 weeks) (spontaneous labor onset: iatrogenic, n:n) | 27/292 (9.2) (12:15)†† | 17/293 (5.8) (8:9)‡‡ | 0.43 (0.22–0.82) (n = 553) |
| Late preterm deliveries (34 weeks+0 days to 36 weeks+6 days) (spontaneous labor onset: iatrogenic, n:n) | 22/292 (7.5) (11:11) | 13/293 (4.4) (6:7) | 0.41 (0.20–0.85) (n = 553) |
| PPROM | 19/280 (6.8) | 8/277 (2.9) | 0.39 (0.16–0.97) (n = 526) |
| Preterm deliveries associated with PPROM (spontaneous labor onset: iatrogenic, n:n) | 17/280 (6.1) (8:9) | 5/277 (1.8) (2:3) | 0.21 (0.06–0.69) (n = 526) |
| Cesarean section delivery (elective: emergency, n:n) | 85/292 (29.1) (41:44) | 84/293 (28.7) (34:50) | 0.99 (0.76–1.28) (n = 553) |
| Major postpartum hemorrhage (>1-L blood loss, denominator: all pregnancies reaching ≥24 weeks) | 24/292 (8.2) | 9/294 (3.1) | 0.44 (0.20–0.94) (n = 554) |
| Neonatal outcomes (denominator: all live births ≥24 weeks) | Mean difference (95% CI)# or RR (95% CI)# | ||
| Birth weight (kg) | 3.30 (0.54) | 3.33 (0.55) | 0.05 (−0.03 to 0.13) (n = 553) |
| Large for gestational age (>90th centile adjusted for sex and gestational age**) | 22/292 (7.5) | 21/293 (7.2) | 0.94 (0.54–1.63) (n = 555) |
| Small for gestational age (<10th centile adjusted for sex and gestational age**) | 21/292 (7.2) | 24/293 (8.2) | 1.34 (0.79–2.29) (n = 555) |
| Admission to neonatal unit | 19/290 (6.6) | 24/293 (8.2) | 1.11 (0.57–2.17) (n = 550) |
| Neonatal hypoglycemia requiring dextrose treatment | 24/292 (8.2) | 19/293 (6.5) | 0.79 (0.43–1.48) (n = 553) |
| Neonatal septicemia (positive blood culture) | 0/287 (0) | 2/288 (0.7) | Insufficient to analyze |
Data are mean (SD) or n (%) unless otherwise indicated. RR, risk ratio.
According to International Association of Diabetes and Pregnancy Study Groups criteria (fasting glucose ≥5.1 mmol/L or 1-h glucose ≥10.0 mmol/L or 2-h glucose ≥8.5 mmol/L) (24); includes only women with complete OGTT data at all three time points.
Adjusted for site, ethnicity, maternal age, preconception BMI, household income level, parity, preconception smoking, preconception baseline fasting glucose, family history of diabetes, and offspring’s sex (not applicable for miscarriages).
Includes anomalies in the following categories: in the control group, four cases of karyotypic/multiple anomalies, two cardiovascular, six genitourinary, two respiratory, two musculoskeletal; in the intervention group, five cases of karyotypic/multiple anomalies, three cardiovascular, four genitourinary, three musculoskeletal.
Requiring admission to the hospital for intravenous rehydration with or without significantly deranged biochemistry or weight loss.
Preeclampsia defined as hypertension in pregnancy associated with significant proteinuria or evidence of multisystem disorder; there were no differences in incidence between study groups.
Pregnancy-induced hypertension defined as isolated nonproteinuric hypertension in a previously normotensive woman or aggravation of hypertension during pregnancy; there were no differences in incidence between study groups.
Adjusted for site, ethnicity, maternal age, preconception BMI, household income level, parity, smoking during pregnancy, offspring sex (except for large and small for gestational age), and (where data were available) 28 weeks gestation fasting glucose.
By Royal College of Paediatrics and Child Health 2009 U.K.-World Health Organization growth charts (25). Use of respective local population charts, Fenton growth charts, and World Health Organization INTERGROWTH-21st charts did not materially alter results.
Iatrogenic preterm births include cases of induction of labor and nonlabor cesarean section. Indications for iatrogenic delivery in the control group were as follows: five for PPROM alone, four for PPROM plus another indication (previous cesarean section, vasa previa, breech presentation, maternal medical condition), five for placental-associated conditions (intrauterine growth restriction with or without preeclampsia or placental abruption), and one maternal medical condition.
Indications for iatrogenic delivery in the intervention group were as follows: three for PPROM alone, four for placental-associated conditions (intrauterine growth restriction with or without preeclampsia or placental abruption), one maternal medical condition, and one fetal anomaly with breech presentation.