Gupta 1998.
Methods | Randomised controlled trial. | |
Participants |
Setting: Antenatal clinic of the Department of Obstetrics and Gynaecology, PGIMER, Chandigarh, India. Duration of study: not stated Inclusion criteria: women with “confirmed gestational age, early confirmation of pregnancy, cephalic presentation and with no contraindication for vaginal delivery“ ”at 38 weeks gestation” and “informed consent" received. Ultrasound was done to assess the fetal growth parameters, biophysical profile and placental localization (Page 116). Exclusion criteria: “Women with closed cervix at 38 weeks gestation; known medical disease or medical complications of pregnancy; multiple pregnancy; hydramnios; premature rupture of membranes PROM; vaginal or cervical infection; low lying placenta; intrauterine fetal death; malpresentation; patients in labor; and major degree of cephalopelvic disproportion.” Ultrasound was done to assess the fetal growth parameters, biophysical profile and placental localization (Page 116). Parity: only primigravida included in the study. Bishop score: (Table I, Page 117). Bishop score < 6 Bishop score ≥ 6 |
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Interventions |
Membrane stripping: n = 50 “stripping of membranes was done by digital separation of 2/3 cm of chorionic membranes from lower uterine segment using two circumferential passes of the examining fingers. Thereafter, all patients were followed weekly till delivery or scheduled induction. At onset of labor repeat cervical swabs were taken and placental membranes sent for bacterial culture studies” (Page 116). Control group: n = 50 “Only pelvic examination” (Page 116). Under aseptic precautions all patients were examined by the same person to minimise subjective difference in evaluation |
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Outcomes | Spontaneous onset of labour Vaginal delivery total Spontaneous vaginal birth Assisted vaginal delivery Caesarean section Acute fetal distress Still birth Meconium aspiration TTN Chorioamnionitis Neonatal infection |
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Notes |
Funding: none declared Trial authors’ declaration of interest: none declared Informed consent obtained: “informed consent was taken” Ethical approval: not stated Email sent requesting further information. Reply 31 August 2017 stating author retired. No contact details available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Randomization was done using a computer generated list of random numbers”, page 116. |
Allocation concealment (selection bias) | Unclear risk | “a sealed envelope was opened for each women after entry into the trial.”, page 116. Does not report if the envelope was sequential, opaque or numbered. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: not reported Personnel: not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of attrition bias. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. No evidence of reporting bias. |
Other bias | Low risk | No evidence of other bias. |