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. 2020 Jul 15;2020(7):CD004945. doi: 10.1002/14651858.CD004945.pub5

Tylleskar 1979.

Study characteristics
Methods RCT
Participants Number of women randomised: 112
Setting: Linköping and Motala, Sweden
Study date: not reported
Inclusion criteria
  • Maternal age 18‐30 years for primipara and 18‐35 years for multipara

  • Regular menstrual period before the pregnancy; LMP normal and date known; women usual hormonal contraceptives had at least 3 normal periods after completing the last course

  • Normal symphysis‐fundus distance and weight gain according to gravidogram

  • Previous pregnancies and births normal (birthweight 3‐4 kg)

  • Actual pregnancy normal and head presentation

  • Normal pelvic outlet on clinical examination

  • Primipara with pelvic score of at least 5 points and engaged head; multipara with pelvic score at least 4 points (within 1 week of due date)

  • GA at intervention: expected day of birth +/‐ 2 days


Exclusion criteria
  • Not described


State of cervix: primipara with pelvic score of at least 5 points and engaged head; multipara with pelvic score at least 4 points
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.
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
Notes Funding: not reported
Declaration of interests: not reported
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.