Labour Induction
Conditions
Brief summary
Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor. Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable
Detailed description
study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020
Interventions
DRUGMisoprostol
rupture of membrane early and late
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Group A: Early amniotomy was performed for the participant of the first group at 3 cm cervical dilatation with Kocher's forceps provided the head is well fitted to the cervix. Group B: late amniotomy was performed for the participant of the second group at 7 cm cervical dilatation.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant women at 36 weeks gestation or more 2. Nullipara 3. singleton fetus 4. cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia.
Exclusion criteria
1. Macrocosmic babies with estimated fetal weight of more than 4000 gram 2. Previous uterine scars 3. Pre labor premature rupture of fetal membranes 4. Polyhydramnios.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| successful induction | immediately after intervention | definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction |
| induction-delivery interval | immediately after intervention | duration of labor and amniotomy delivery interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intrapartum meconium | during the intervention | intrapartum meconium passage |
| misoprostol doses administered | during the intervention | number of misoprostol doses administered |
| newborn admission in the neonatal intensive care unit | immediately after intervention | newborn admission in the neonatal intensive care unit (NICU). |
| Apgar score | during the intervention | Apgar score less than 7 at 1 and 5 minutes |
| the need for augmentation of labor | during the intervention | the need for augmentation of labor by oxytocin and perinatal outcomes included cord prolapse and abnormal FHR changes during labor |
Countries
Egypt
Outcome results
None listed