Early Versus Late Amniotomy Following EAB Cervical Ripening
- Conditions
- Induction of Labor Affected Fetus / Newborn
- Interventions
- Other: Amniotomy
- Registration Number
- NCT04216628
- Lead Sponsor
- Assuta Ashdod Hospital
- Brief Summary
The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.
- Detailed Description
Induction of labor is a common obstetric procedure with a reported rate of 23.3% in 2012 in the United State. It has been recently reported that Induction of labor at full term in uncomplicated singleton gestations is not associated with increased risk of cesarean delivery and overall has similar outcomes compared to expectant management.
Induction of labor in women with an unripened cervix is comprised of two stages, cervical ripening followed by augmentation of labor.
Extra amniotic balloon inflation is a widespread mechanical method of cervical ripening that commonly results in a ripened cervix open to 3-4 cm without significant uterine contractions. At this point the clinician may opt to perform artificial rupture of membranes or rather first begin oxytocin infusion delaying amniotomy to later stages of labor. A retrospective cohort showed early amniotomy after Foley balloon catheter removal was associated with shorter duration of labor induction among nulliparous women.In accordance, an RCT investigating the efficacy of early amniotomy in nulliparous women showed this practice resulted in labor shortening without increasing the rate of cesarean section, yet these women were treated by different methods for cervical ripening. Contradicting results were shown in a randomized controlled trial addressing the very question of early versus late amoniotomy after balloon ripening, concluding that postponing amniotomy until active labor commences results in a reduction of dystocia indicated cesarean section. However no distinction was made in this study between nulliparous and multiparous parturients. Since these comprise different groups with distinct labor curves, the question remains whether one should consider parity when deciding to perform early vs late amniotomy following balloon expulsion.
Both Amniotomy and Oxytocine infusion are part of the routine protocol and necessary procedures for induction of labor. Adverse outcome of amniotomy includes fetal heart rate changes, cord prolapse and intrapartum fever when labor is prolonged. Adverse outcome of oxytocine include hypertonus and fetal heart rate changes requiring cessation of oxytocine infusion (as in routine protocol) and intrapartum fever if labor is prolonged (not due to oxytocine infusion per se). Most of the patients admitted for induction of labor will need both amniotomy and oxytocine, however the role of the order of these two procedures is unclear ,as well as whether the order of these procedures affect the rate of adverse outcome.
The objective of this study is to investigate the course of labor in early versus late amniotomy following balloon cervical ripening in women undergoing term induction of labor stratified by parity.
STUDY PROTOCOL Multicenter randomized control trial that will be conducted in 4 medical centers in Israel.
Women with a singleton viable gestation undergoing indicated labor induction at term (37-42 weeks of gestation) who undergoing induction of labor at term with a low bishop score\<4 who require extra amniotic balloon cervical ripening will be asked to participate in the study. Written informed consent will be obtained from all patients.
Early amniotomy- Amniotomy performed as the exclusive primary intervention to augment labor following expulsion of the EAB regardless of cervical dilatation.
Late amniotomy- EAB expulsion is followed by oxytocin infusion at increasing increments as the primary intervention as an exclusive intervention for at least 2 hours.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 146
- Gestational age 37-42 weeks
- Singleton pregnancy
- Vertex presentation
- Medical indication for induction of labor
- Need for cervical ripening (Bishop score <=6)
- Consent to participate in the study
- Women age at or >18 years
- Multiple pregnancies
- Preterm pregnancy
- Previous cesarean section
- Uterine malformation
- Withdrawal of consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Late amniotomy group Amniotomy Oxytocin infusion will begin as per local standard dose protocol. Amniotomy will be performed no earlier than 2 hours following the commence of oxytocin infusion Early amniotomy group Amniotomy Amniotomy will be performed as the exclusive primary intervention. Oxytocin infusion will begin as per local standard dose protocol no earlier than 2 hours following amniotomy.
- Primary Outcome Measures
Name Time Method Delivery within 24 hours Up to 96 Hours The proportion of women that delivered within 24 hours of induction
Time to delivery Up to 96 Hours The time from induction defined as the primary intervention following balloon expulsion to delivery.
- Secondary Outcome Measures
Name Time Method Operative delivery Up to 96 Hours Operative delivery rates and indications
Intrapartum fever Up to 96 Hours Fever \>38 degrees Celsius during labor
Cesarean delivery Up to 96 Hours Cesarean delivery rates and indications
Post partum hemorrhage Up to 7 days Estimation of obstetrician \>500cc bleeding post partum for vaginal delivery or\>1000 cc at cesarean section
Neonatal outcomes- Apgar 10 minutes Apgar score
Postpartum fever during the postpartum hospital stay Up to 7 days Fever \>38 degrees Celsius \> 24hours after delivery
Neonatal outcomes- infection Up to 30 days Neonatal fever/sepsis
Neonatal outcomes - PH umbilical 10 minutes PH of vein and or artery of umbilical cord
Neonatal outcomes- NICU admission Up to 30 days Admission to Neonatal Intensive Care Unit
Trial Locations
- Locations (1)
Assuta Ashdod
🇮🇱Ashdod, Israel