Magann 1998b.
Methods | Randomised controlled trial. | |
Participants |
Setting: Naval Medical Center, San Diego, California, USA (Page 1279). Duration of study: 6 months (March 1996 to September 1996) (Page 1279). Participants randomised: n = 105 Inclusion criteria: no contraindication to a vaginal delivery. Bishop score ≤ 4. Uncomplicated pregnancy. ≥ 41 weeks' gestation. Informed consent signed (Page 1279). Exclusion criteria: contraindication to a pelvic examination, i.e. placenta praevia, rupture of membranes (Page 1279). Parity: mixed. Both nulliparous and multiparous women included (Page 1280, Table II). Bishop score: Bishop score at entry (mean +/‐SD) recorded |
|
Interventions |
Membrane sweeping group: n = 35 “daily membrane stripping performed” (Page 1280). Prostaglandin group: n = 35 “0.5mg of prostaglandin E2 (PGE2) gel placed into the cervix on a daily basis as an outpatient.” (Page 1280). Control group: n = 35 “gentle daily cervical examination” “All patients were examined to determine Bishop scoring by one of the two examiners who were blinded to group assessment.” “If the Bishop score totaled ≥8 or the patient reached the forty second week of pregnancy the patient was admitted for induction of labour.” All patients received a modified biophysical profile (NST and amniotic fluid index) every 3 days except for those women in the prostaglandin group who had daily biophysical profiling after the insertion of the intracervical prostaglandin (Page 1280). |
|
Outcomes | Spontaneous onset of labour Formal induction of labour Induction at 42 weeks Spontaneous vaginal delivery Caesarean section delivery Forceps delivery Apgar < 7 at 5 minutes Cost analysis |
|
Notes |
Funding: “Departments of Obstetrics and Gynecology, Naval Medical Center and University of Mississippi Medical Center. Supported in part by the Vicksburg Hospital Medical Foundation.” page 1279. Trial authors’ declaration of interest: none declared Informed consent obtained: yes Ethical approval: “study was approved by the Institutional Review Board” page 1280. Unable to source contact details for Dr Magann |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “patients were randomly assigned to one of the groups by drawing the next in a series of opaque sealed envelopes that had been generated from a random number table”, page 1280. |
Allocation concealment (selection bias) | Unclear risk | "by drawing next in series of opaque sealed envelopes” page 1280. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: not reported Personnel: “All patients were examined to determine Bishop scoring by one of the two examiners who were blinded to group assessment.” Further blinding of personnel not discussed, page 1280. |
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 | No evidence of selective reporting bias. |
Other bias | Low risk | No evidence of other bias. |