Early Versus Late Amniotomy Following EAB Cervical Ripening

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04216628
• Other study ID #: 31-19-AAA
• Status: Terminated
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: January 11, 2023

Study information

• Verified date: August 2023
• Source: Assuta Ashdod Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Other:
• Amniotomy
Artificial rupturing of membranes and IV infusion of Oxytocin

Locations

Country	Name	City	State
Israel	Assuta Ashdod	Ashdod

Sponsors (4)

Lead Sponsor	Collaborator
Assuta Ashdod Hospital	Rambam Health Care Campus, The Baruch Padeh Medical Center, Poriya, Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to delivery	The time from induction defined as the primary intervention following balloon expulsion to delivery.	Up to 96 Hours
Primary	Delivery within 24 hours	The proportion of women that delivered within 24 hours of induction	Up to 96 Hours
Secondary	Cesarean delivery	Cesarean delivery rates and indications	Up to 96 Hours
Secondary	Operative delivery	Operative delivery rates and indications	Up to 96 Hours
Secondary	Intrapartum fever	Fever >38 degrees Celsius during labor	Up to 96 Hours
Secondary	Postpartum fever during the postpartum hospital stay	Fever >38 degrees Celsius > 24hours after delivery	Up to 7 days
Secondary	Post partum hemorrhage	Estimation of obstetrician >500cc bleeding post partum for vaginal delivery or>1000 cc at cesarean section	Up to 7 days
Secondary	Neonatal outcomes- Apgar	Apgar score	10 minutes
Secondary	Neonatal outcomes - PH umbilical	PH of vein and or artery of umbilical cord	10 minutes
Secondary	Neonatal outcomes- NICU admission	Admission to Neonatal Intensive Care Unit	Up to 30 days
Secondary	Neonatal outcomes- infection	Neonatal fever/sepsis	Up to 30 days