Early Versus Late Amniotomy Following EAB Cervical Ripening
NCT ID: NCT04216628
Last Updated: 2023-09-01
Study Results
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Basic Information
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TERMINATED
NA
146 participants
INTERVENTIONAL
2020-02-10
2023-01-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. 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
TREATMENT
NONE
Study Groups
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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.
Amniotomy
Artificial rupturing of membranes and IV infusion of Oxytocin
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
Amniotomy
Artificial rupturing of membranes and IV infusion of Oxytocin
Interventions
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Amniotomy
Artificial rupturing of membranes and IV infusion of Oxytocin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Singleton pregnancy
3. Vertex presentation
4. Medical indication for induction of labor
5. Need for cervical ripening (Bishop score \<=6)
6. Consent to participate in the study
7. Women age at or \>18 years
Exclusion Criteria
2. Preterm pregnancy
3. Previous cesarean section
4. Uterine malformation
5. Withdrawal of consent.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Wolfson Medical Center
OTHER_GOV
Rambam Health Care Campus
OTHER
The Baruch Padeh Medical Center, Poriya
OTHER_GOV
Assuta Ashdod Hospital
OTHER
Responsible Party
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Eran Brazilay, MD PhD
Senior physician, OBGYN department
Principal Investigators
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Yael Ganor Paz, MD
Role: PRINCIPAL_INVESTIGATOR
Assuta Ashdod medical center
Locations
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Assuta Ashdod
Ashdod, , Israel
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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31-19-AAA
Identifier Type: -
Identifier Source: org_study_id
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