Clinical trial NCT04216628: Early Versus Late Amniotomy Following EAB Cervical Ripening
Official title: Early Versus Late Amniotomy Following EAB Cervical Ripening - Does Parity Matter?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Keywords: Amniotomy
Cervical ripening
Oxytocin
Exrea amniotic baloon
Lead sponsor: Assuta Ashdod Hospital
Sponsor class: OTHER
Collaborators: name: Wolfson Medical Center
name: Rambam Health Care Campus
name: The Baruch Padeh Medical Center, Poriya
First posted: 2020-01-03
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. 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.
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
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Gestational age 37-42 weeks
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:

1. Multiple pregnancies
2. Preterm pregnancy
3. Previous cesarean section
4. Uterine malformation
5. Withdrawal of consent.

Primary outcomes:
measure: Time to delivery
timeFrame: Up to 96 Hours
measure: Delivery within 24 hours
timeFrame: Up to 96 Hours
Secondary outcomes:
measure: Cesarean delivery
timeFrame: Up to 96 Hours
measure: Operative delivery
timeFrame: Up to 96 Hours
measure: Intrapartum fever
timeFrame: Up to 96 Hours
measure: Postpartum fever during the postpartum hospital stay
timeFrame: Up to 7 days
measure: Post partum hemorrhage
timeFrame: Up to 7 days
measure: Neonatal outcomes- Apgar
timeFrame: 10 minutes
measure: Neonatal outcomes - PH umbilical
timeFrame: 10 minutes
measure: Neonatal outcomes- NICU admission
timeFrame: Up to 30 days
measure: Neonatal outcomes- infection
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod
Study officials:
affiliation: Assuta Ashdod medical center
name: Yael Ganor Paz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.