Kashanian 2006.
Methods | Randomised controlled trial | |
Participants |
Setting: Akbarabadi Teaching Hospital in Tehran, Iran Duration of study: not reported Participants randomised: N = 122 Inclusion criteria: “gestational age of 39 weeks (with dates determined on the basis of the last menstrual periods and ultrasound performed during the 1st trimester), singleton gestation, vertex presentations, and intact membranes”.” (Page 42) Exclusion criteria: “clinically significant vaginal bleeding, placenta previa, severe cervicitis, evidence of spontaneous labor (more than three painful contractions in 10 min), a known contraindication to labor induction (e.g., prior vertical uterine incision, acute fetal compromise, active herpes), systemic disorder, decreased fetal movements, any sign of fetal distress and any high‐risk pregnancy, or inability to give informed consent.” (Page 42) Parity: mixed. Both nulliparous and multiparous women included (Page 42). Bishop score: baseline Bishop score mean +/‐SD recorded |
|
Interventions |
Membrane stripping (N = 50): “Sweeping was performed by one of the investigators. Sweeping was performed based on a standard method. As much of the membranes as possible was separated from the lower segment. If the cervix did not allow a finger, it was massaged for 2 min to stimulate prostaglandin release. The women were observed for a few hours after the procedure and were discharged, if they were well. The patients were instructed to admit to the labor ward, if they had leaking, labor pain, or excessive vaginal bleeding” (Page 42). Control group (N = 51): “only vaginal examination for determining Bishop score. Vaginal examination was performed by the same investigator for both groups. “ “Women were admitted to the labor ward whenever they had labor pain. In others, pregnancies were followed till 41 weeks, in case of lack of labor pain, induction was started to terminate labor.” (Page 42). |
|
Outcomes | Puerperal fever Caesarean section |
|
Notes |
Funding: not stated Trial authors’ declaration of interest: not stated Informed consent obtained: “written informed consent” Ethical approval: “approval from the Hospital Ethics Committee” Unable to contact author. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “four parts, block random using sealed, sequentially distributed envelopes to which the letters A, B, C, and D had been allocated”, page 42. |
Allocation concealment (selection bias) | Low risk | “sealed, sequentially distributed envelopes to which the letters A, B, C, and D had been allocated: the letters A and C to the sweeping group and the letters B and D to the control group; the patients chose the envelopes which were opened by the investigator, and according to the letters, the group of patients was determined”, Page 42. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: unclear if participants blinded once allocated to groups. “the patients choose the envelopes, which were opened by the investigator” Page 42 Personnel: not blinded. "the patients chose the envelopes which were opened by the investigator, and according to the letters, the group of patients was determined”, Page 42. “Sweeping was performed by one of the investigators, and vaginal examination also was performed by the same investigator for the control group.” “Follow‐up of the patients was performed by another investigator who was blinded to the groups of patients; therefore, at this stage, neither the investigator nor the patients knew which was the study group.” Page 42. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | “Follow‐up of the patients was performed by another investigator who was blinded to the groups of patients; therefore, at this stage, neither the investigator nor the patients knew which was the study group.” page 42. |
Incomplete outcome data (attrition bias) All outcomes | High risk | “Twenty‐one women who did not give birth in our hospital were excluded from the study”, < 20%. N = 122 Intervention group = 50 (60‐10) Control group = 51 (62‐11) Page 42. |
Selective reporting (reporting bias) | Unclear risk | “Data regarding premature rupture of membranes, abnormal bleeding during hospitalization, Bishop score, timing of delivery, mode of delivery, and birth weight were collected.” For mode of delivery only data given for caesarean section |
Other bias | Low risk | No evidence of other bias |