Goldenberg 1996.
Methods | Randomised controlled trial. | |
Participants |
Setting: antenatal Unit, Department of Obstetrics and Gynecology, The Chaim Sheba Medical Center, Israel. Page 130 Duration of study: 17 months (1 January 1992 to 30 June 1993). Page 130 Inclusion criteria: all term patients who arrived at the unit and had a history of regular periods. This “unit accepts low‐risk pregnant women and routinely does follow‐up by means of a non‐stress test and ultrasonographic evaluation at ≥ 38 weeks to decrease mortality and morbidity of the fetus. The gestational age was ascertained by using the last‐known menstrual period, ultrasound examination before 10 weeks’ gestation, and no size/date discrepancy by uterine size assessment.” “A non‐stress test, blood pressure and urine analysis are routinely carried out on all the patients of the antenatal unit. Only low‐risk pregnant patients who fulfilled the above criteria underwent stretching of the cervix and Stripping of the fetal membranes.” Page 130 Exclusion criteria: "None refused inclusion" Page 130 Parity: mixed. Both nulliparous and multiparous women included (table 1 page 130 of study). Bishop score: Baseline Bishop score recorded (Table 1 page 130). Bishop score at 38‐40 weeks recorded (Table 3 page 133). Bishop score at 41‐43 weeks recorded (Table 3 page 133). |
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Interventions |
Membrane stripping: n = 152. "The procedure was performed once at term by 2 of the authors (M.G. and D.B.) using clean examination gloves and an obstetric cream. Stretching of the cervix and vagina was accomplished as described by Ferguson (3), and stripping of the membranes was accomplished by digital separation of the membranes from the lower uterine segment with 1 or 2 circumferential rotations." Page 130 Control group: n = 141 “A pelvic examination was performed by palpating the cervix for Bishop’s scoring”. “The interval from the procedure to spontaneous labor was recorded, defining spontaneous labor as labor on self‐admission of the patients to the delivery room due to painful regular contractions occurring twice every 10 min, or more frequently. A cervical dilatation of 2‐3 cm on entry to the labor ward was considered arbitrary, to indicate the active phase of labor in women who were admitted, or rupture of the fetal membrane at term with contractions.” Page 130 |
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Outcomes | Augmentation Amnionitis Caesarean section Maternal febrile morbidity Apgar score < 7 at 5 minutes |
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Notes |
Funding: none declared Trial authors’ declaration of interest: none declared Informed consent obtained: “Informed consent was obtained from all the patients”. Page 130 Ethical approval: not stated. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “All patients were assigned by computer randomization to a stretching/stripping group or to a non‐stretching/stripping group” page 130 |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Personnel: “The procedure was performed once at term by two of the authors (M.G. and D.B.)” Page 130 Participants: blinding of participants not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 302 participants enrolled. 9 lost to follow‐up when they requested "to halt the procedure" page 130. 293 participants randomised. Intervention group n = 152, Control group n = (150‐9) 141. It is noted that “An additional nine patients from the stretching/stripping group were excluded because of difficulty in performing the procedure." page 130. |
Selective reporting (reporting bias) | Unclear risk | Mode of delivery is a stated outcome, however only caesarean section is reported on, Page 130. Fetal outcome post delivery only reported as “postpartum complications…not statistically different”, no detailed data given, Page 130. |
Other bias | Low risk | No evidence of other bias |