- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04216628
Early Versus Late Amniotomy Following EAB Cervical Ripening
Early Versus Late Amniotomy Following EAB Cervical Ripening - Does Parity Matter?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yael Ganor Paz, MD
- Phone Number: 972-72-3398423
- Email: yaelgano@assuta.co.il
Study Locations
-
-
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Ashdod, Israel
- Assuta Ashdod
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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Artificial rupturing of membranes and IV infusion of Oxytocin
Other Names:
|
Other: 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
|
Artificial rupturing of membranes and IV infusion of Oxytocin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to delivery
Time Frame: Up to 96 Hours
|
The time from induction defined as the primary intervention following balloon expulsion to delivery.
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Up to 96 Hours
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Delivery within 24 hours
Time Frame: Up to 96 Hours
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The proportion of women that delivered within 24 hours of induction
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Up to 96 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cesarean delivery
Time Frame: Up to 96 Hours
|
Cesarean delivery rates and indications
|
Up to 96 Hours
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Operative delivery
Time Frame: Up to 96 Hours
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Operative delivery rates and indications
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Up to 96 Hours
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Intrapartum fever
Time Frame: Up to 96 Hours
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Fever >38 degrees Celsius during labor
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Up to 96 Hours
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Postpartum fever during the postpartum hospital stay
Time Frame: Up to 7 days
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Fever >38 degrees Celsius > 24hours after delivery
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Up to 7 days
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Post partum hemorrhage
Time Frame: Up to 7 days
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Estimation of obstetrician >500cc bleeding post partum for vaginal delivery or>1000 cc at cesarean section
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Up to 7 days
|
Neonatal outcomes- Apgar
Time Frame: 10 minutes
|
Apgar score
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10 minutes
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Neonatal outcomes - PH umbilical
Time Frame: 10 minutes
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PH of vein and or artery of umbilical cord
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10 minutes
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Neonatal outcomes- NICU admission
Time Frame: Up to 30 days
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Admission to Neonatal Intensive Care Unit
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Up to 30 days
|
Neonatal outcomes- infection
Time Frame: Up to 30 days
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Neonatal fever/sepsis
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Up to 30 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yael Ganor Paz, MD, Assuta Ashdod Medical Center
Publications and helpful links
General Publications
- Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
- Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24.
- Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x.
- ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
- Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.
- Saccone G, Berghella V. Induction of labor at full term in uncomplicated singleton gestations: a systematic review and metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2015 Nov;213(5):629-36. doi: 10.1016/j.ajog.2015.04.004. Epub 2015 Apr 13.
- Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032.
- Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31-19-AAA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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