Tylleskar 1979.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 112
Setting: Linköping and Motala, Sweden Study date: not reported Inclusion criteria
Exclusion criteria
State of cervix: primipara with pelvic score of at least 5 points and engaged head; multipara with pelvic score at least 4 points |
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Interventions |
Induction group (n = 57): after AROM, an open‐ended saline‐filled catheter was inserted for measurement of intraamniotic pressure and a scalp electrode applied for continuous recording of FHR. IV oxytocin (using Cardiff Infusion System Mark II) was started 15 minutes later at 1 mU/minute, increased continuously until the intensity of contractions was at least 33 mm Hg, with a frequency of at least 1 contraction every 150 seconds; the infusion rate doubled every 12.5 minutes. versus EM group (n = 55): women were asked to come to the delivery ward as soon as labour started; external CTG recordings were made until definite labour activity was demonstrated. AROM was performed, a catheter and scalp electrode applied when for primipara the cervix was at least 50% effaced and dilated more than 2 cm, and for multipara when the cervix was dilated to 3 cm. If the pregnancy lasted more than 14 days beyond the estimated time of birth labour was induced using IV oxytocin. |
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Outcomes |
Mother: duration of labour; uterine activity at 6 cm cervical dilatation; total amount of oxytocin used; FHR patterns (early decelerations; late decelerations; bradycardia); amount of bleeding during the third stage of labour; mode of birth (vacuum extraction); placental retention; maternal pH at birth; analgesia (pudendal block, nitrous oxide, pethidine/atarax); women's experiences of the birth Baby: birthweight; birth asphyxia; Apgar score at 1 and 5 minutes; baby pH; lowest weight in first week; haemoglobin and haematocrit in umbilical vein and day 2; bilirubin levels day 1‐3; 4 dimensions of the Brazelton Scale |
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Notes |
Funding: not reported Declaration of interests: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generated was not reported. |
Allocation concealment (selection bias) | Unclear risk | The method of allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinded outcome assessment was not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 112 women were randomised. 13/57 in the induction group and 12/55 in the EM group went into labour before the expected due date and were excluded. 3 further women were excluded – 1 in the EM group birthed rapidly and data collection was not possible; 1 woman in each group had a caesarean due to feto‐pelvic disproportion. Thus 43/57 in the induction group and 41/55 in the EM group were analysed; overall 84/112 (75%). |
Selective reporting (reporting bias) | High risk | Results for a number of outcomes are reported incompletely, e.g. "Nor were there any differences in maternal pH at delivery"; "Analgesia in the form of pudendal block or nitrous oxide was given in the same frequency in the two groups;" and "An analysis of the questionnaire with respect to the patients experiences of the delivery indicate a positive attitude... No statistical differences between groups were found." |
Other bias | Unclear risk | Limited methodological detail provided. The only baseline characteristics reported were age, pelvic score and number of previous pregnancies, and only for women analysed. |