Postpartum vaginal blood loss following two different methods of cervical ripening

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: The different groups receive different interventions at the same time during study, and allocation to either intervention group was randomised. Allocation sequence was generated by simple randomization using a randomization table created by a computer software program. The allocation sequence/code was concealed from the person allocating the participants to the intervention arms using sealed opaque envelopes. Masking: open‐label (masking was not used) Control group: Foley catheter, single insertion into the intra‐cervical extra‐amniotic space and left in‐situ until the catheter was spontaneously expelled, at less than but not greater than 12 hours duration Experimental group: Vaginal misoprostol, 50 microgram inserted into the posterior vaginal fornix 6 hourly and stopped when the participant was having adequate uterine contractions or to a maximum of 4 doses under 24 hours Once the fetal head had crowned, a plastic bag was placed under the patient to collect the blood and hind water following the delivery of the fetus and the placenta. It did not require sterilization and was used in the dorsal, lateral, or lithotomy positions. The bag was left in situ until the birth attendant was no longer concerned about blood loss, such as when a sanitary towel was applied to the vulva. Thereafter the collected blood was poured into a graduated measuring cup, promptly read and recorded. The sanitary towel was left in place to collect blood lost per vagina until 6 hours postpartum and then weighed to determine the amount of blood lost. For women undergoing caesarean section the use of suction tubes and bottles and weighing of the abdominal mops, gauze and swabs was used to determine the amount of blood lost. CONDITION: Induction of labor ; Pregnancy and Childbirth PRIMARY OUTCOME: Postpartum vaginal blood loss, measured by collecting blood using an under buttocks plastic collection bag and by perineal pad from the crowning of the fetal head (second stage of labor) up to 6 hours post delivery SECONDARY OUTCOME: 1. Induction delivery interval, measured from the start of intervention to time of childbirth ; 2. Wellness of the baby, assessed using the Apgar score score at 1 minute and 5 minute post delivery ; 3. Neonatal cord blood pH at time of cord clamping following delivery of the baby INCLUSION CRITERIA: 1. 37 completed weeks up to 41 completed weeks plus 3 days 2. Bishop score of <5 3. A live singleton fetus with cephalic presentation at term with intact membranes with no evidence of labor 4. No contraindications to a vaginal delivery 5. Up to the third parity
Epistemonikos ID: 0b2afce14eaa8027c091412eac0a6486dff4fc6b
First added on: Aug 23, 2024