Early Versus Late Amniotomy Following EAB Cervical Ripening

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Versus Late Amniotomy Following EAB Cervical Ripening - Does Parity Matter?

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Other: Amniotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Multiple pregnancies Preterm pregnancy Previous cesarean section Uterine malformation Withdrawal of consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: For the early amniotomy group 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. For the late amniotomy group 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Early amniotomy group<br>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. | Other: Amniotomy<br>* Artificial rupturing of membranes and IV infusion of Oxytocin<br>* Other names: Oxytocin;|
| Other: Late amniotomy group<br>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 | Other: Amniotomy<br>* Artificial rupturing of membranes and IV infusion of Oxytocin<br>* Other names: Oxytocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to delivery | The time from induction defined as the primary intervention following balloon expulsion to delivery. | Up to 96 Hours | 
| Delivery within 24 hours | The proportion of women that delivered within 24 hours of induction | Up to 96 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean delivery | Cesarean delivery rates and indications | Up to 96 Hours | 
| Operative delivery | Operative delivery rates and indications | Up to 96 Hours | 
| Intrapartum fever | Fever >38 degrees Celsius during labor | Up to 96 Hours | 
| Postpartum fever during the postpartum hospital stay | Fever >38 degrees Celsius > 24hours after delivery | Up to 7 days | 
| Post partum hemorrhage | Estimation of obstetrician >500cc bleeding post partum for vaginal delivery or>1000 cc at cesarean section | Up to 7 days | 
| Neonatal outcomes- Apgar | Apgar score | 10 minutes | 
| Neonatal outcomes - PH umbilical | PH of vein and or artery of umbilical cord | 10 minutes | 
| Neonatal outcomes- NICU admission | Admission to Neonatal Intensive Care Unit | Up to 30 days | 
| Neonatal outcomes- infection | Neonatal fever/sepsis | Up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amniotomy, Cervical ripening, Oxytocin, Exrea amniotic baloon