Labor, Induced, Amniotomy
Conditions
Keywords
labor, Amniotomy, induction
Brief summary
Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth. A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health. Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown. The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.
Interventions
PROCEDUREAmniotomy
artificial rupture of the amniotic sac
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years old * Full term (36 weeks and 3 days of gestation reached) * Singletion gestation in cephalic presentation * Bishop score of ≥ 6
Exclusion criteria
* Prior uterine surgery, previous cesarean section * Ruptured membranes * Spontaneous labor * Multifetal pregnancy * Dystocic presentation * Fetal head not fixed at pelvic brim * Macrosomia * Hydramnios * Severe fetal growth restriction * Major fetal anomaly * Women with HIV, hepatitis C, hepatitis B * Women with medical conditions contraindication to a vaginal delivery * Women with COVID-19 infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to active phase of labor | At delivery | Total time from initiation oxytocin infusion to reaching 5 cm cervical dilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean delivery rate | At delivery | Rate of cesarean section |
| Time to vaginal delivery | At delivery | Total time from initiation of labor induction to vaginal delivery |
| Maternal outcomes | From inclusion to discharge, up to 2 weeks | Intrapartum and postpartum fever, postpartum haemorrhage, chorioamnionitis, endometritis |
| Fetal and neonatal outcome | From inclusion to discharge, up to 2 weeks | Fetal distress, birth asphyxia, acidosis, sepsis |
Countries
Tunisia
Outcome results
None listed