Labour Induction Clinical Trial
— RCTOfficial title:
Early Versus Late Amniotomy on Labour Induction in Nulliparous Women
Verified date | August 2020 |
Source | Menoufia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 140 |
Est. completion date | March 20, 2020 |
Est. primary completion date | January 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Menoufia University hospital | Shibin Al Kawm | Menoufia |
Lead Sponsor | Collaborator |
---|---|
Menoufia University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | successful induction | definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction | immediately after intervention | |
Primary | induction-delivery interval | duration of labor and amniotomy delivery interval | immediately after intervention | |
Secondary | misoprostol doses administered | number of misoprostol doses administered | during the intervention | |
Secondary | the need for augmentation of labor | the need for augmentation of labor by oxytocin and perinatal outcomes included cord prolapse and abnormal FHR changes during labor | during the intervention | |
Secondary | intrapartum meconium | intrapartum meconium passage | during the intervention | |
Secondary | Apgar score | Apgar score less than 7 at 1 and 5 minutes | during the intervention | |
Secondary | newborn admission in the neonatal intensive care unit | newborn admission in the neonatal intensive care unit (NICU). | immediately after intervention |
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