Labour induction in women at term with unfavourable cervix

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
INTERVENTION: Women who were assigned randomly to receive the sustained‐released dinoprostone (Propess®, Vitalis, Turkey) with concurrent high‐dose oxytocin (Group A) had a single dose placed high into the vaginal fornix. This sustained‐released product releases dinoprostone at a low but steady rate (0.3 mg/h). It remained in the vagina for up to 12 hours, as recommended by the manufacturer. At the same time, oxytocin infusion at 4 milliunits/min was started for all participants. Oxytocin infusion was doubled every 30 minutes to a maximum of 40 milliunits/min or until four contractions in 10 minutes was achieved. Women who were assigned randomly to receive the sustained‐released dinoprostone followed six hours later by high‐dose oxytocin (Group B) had a single dose placed high into the vaginal fornix. A standart high‐dose of intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 4 mU/min was increased at 30 minute intervals by 4 mU/min to a maximum dose 40 mU/min or until four contractions in 10 minutes was achieved. CONDITION: Labour induction ; Pregnancy and Childbirth ; Abnormalities of forces of labour PRIMARY OUTCOME: Number (rate) of women who went to vaginally deliver within 24 hours of the initiation of the protocol. SECONDARY OUTCOME: 1. Incidence of excess uterine activity (uterine hyperstimulation or uterine tachysystole); 2. Labour induction‐to‐delivery interval; 3. Labour induction‐to‐active phase interval (defined as at least 6 uterine contractions per 20‐minute intervals, with at least 70% effaced cervix and a cervical dilatation of greater than or equal to 4); 4. Total number of doses of dinoprostone pessary used; 5. Meconium‐stained liquor; 6. Mode of delivery; 7. Instrumental delivery rate; 8. Maternal satisfaction score for the birth process obtained within 24 hours of delivery (a visual analog scale (VAS) with a range of 0 to 10, with higher score denoting greater satisfaction, was used to gauge maternal satisfaction); 9. Visual analogue scale pain score (ranged from 0 to 10, with 0 representing no pain to 10 representing unbearable pain); 10. Rates of maternal and neonatal complications:; 10.1. Maternal complications included:; 10.1.1. Incidence of maternal side effects (nausea, vomiting, diarrhoea, pyrexia); 10.1.2. Postpartum haemorrhage (blood loss greater than 500); 10.1.3. Third‐ or fourth‐degree lacerations; 10.1.4. Intrapartum chorioamnionitis (defined as temperature greater than or equal to 38°C accompanied by maternal or fetal tachycardia [greater than 160 beats/min], uterine tenderness, malodorous amniotic fluid discharge, and/or maternal leukocytosis [white blood cell count greater than 15,000 cell/min^3]); 10.1.5. Postpartum endometritis (defined as temperature greater than or equal to 38°C accompanied by uterine tenderness and/or purulent or foul‐smelling lochiae beyond the first 24 hours after delivery); 10.2. Neonatal complications noted were:; 10.2.1. Apgar scores of less than 7 at 5 minutes; 10.2.2. Neonatal jaundice; 10.2.3. Rate of admission to the neonatal intensive care unit; ; Seondary analysis based on parity was also planned. INCLUSION CRITERIA: 1. Single live fetus in cephalic presentation 2. Gestational age greater than or equal to 37 weeks as determined by the last menstrual period or by a first‐ or second‐trimester ultrasound scan 3. Bishop score less than or equal to 4 4. Females aged 20 ‐ 40 years
Epistemonikos ID: 5a0f14ba5f96eed100ca80aec527a6a6abd1c060
First added on: Aug 22, 2024