Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial

NCT03504670 | Completed DMC

• 1 other identifier: UAB_EarlyAROM
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and augment labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients (≥37 weeks' gestation). The utility of amniotomy in preterm patients (\<37 weeks' gestation) undergoing medically-indicated induction of labor is unknown. However, it remains a commonly used strategy. We will conduct a trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the obstetrician has decided to induce labor for a medical indication. We hypothesize that more women in the early amniotomy group will require cesarean delivery, and the duration of labor will increase in the early amniotomy group.

Conditions

Preterm Pregnancy; Labor Induction

Keywords

Labor induction; Cesarean delivery; Preterm labor induction; Duration of labor induction

Outcome Measures

Primary Outcomes (1)

• Cesarean delivery

  Proportion of women requiring cesarean delivery

  Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.

Secondary Outcomes (4)

• Interval from induction onset to delivery

  Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.

• Interval from induction onset to vaginal delivery

  Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.

• Composite maternal morbidity

  Measured from start of induction of labor up to 42 days following delivery

• Composite neonatal morbidity

  Measured up to 28 days of life for the newborn

Study Arms (2)

Early amniotomy

EXPERIMENTAL

Women randomized to early amniotomy will have their membranes ruptured in usual fashion using an amniotomy hook when the cervix is less than 4cm dilated. This will occur after cervical ripening has taken place, with 1) a cervical Foley balloon catheter with or without oxytocin and/or 2) misoprostol. Prior to amniotomy, the obstetric provider will assess whether or not the fetal head is engaged. If the fetal head is not engaged (applied to the cervix), amniotomy will be deferred. The patient will be examined every 2 hours until amniotomy can be safely performed (in keeping with our institutional standard of care to examine women every 2-4 hours in labor).

Procedure: Early Amniotomy

Late amniotomy

EXPERIMENTAL

Women randomized to late amniotomy will have their membranes ruptured once the cervix reaches at least 4cm dilation. This will occur after cervical ripening has taken place, with 1) a cervical Foley balloon catheter with or without oxytocin and/or 2) misoprostol. If the cervix fails to reach 4cm dilation 12 hours following cervical ripening, amniotomy will be performed.

Procedure: Late Amniotomy

Interventions

Early Amniotomy PROCEDURE

This intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed prior to the cervix being dilated 4cm.

Early amniotomy

Late Amniotomy PROCEDURE

This intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed once the cervix is at least 4cm dilated.

Late amniotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton gestation
• Gestational age at randomization between 23.0 and 35.6 weeks
• Induction of labor planned for maternal or fetal indications
• Reassuring fetal status
• Vertex presentation

You may not qualify if:

• Plan for cesarean delivery or contraindication to labor
• Cervix ≥4cm dilated at start of induction
• Signs of spontaneous labor (active contractions with cervical change)
• Ruptured membranes
• Chorioamnionitis
• Intrauterine fetal demise
• Known major fetal anomaly
• Participation in any other clinical trial involving the course of labor
• Maternal hepatitis B, C, or HIV infection (or unknown status)
• Deferring intrapartum fetal monitoring and/or cesarean section for any reason (for example, after periviability counseling)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmigham, Women and Infants' Center

Birmingham, Alabama, 35233, United States

Location

Related Publications (11)

• Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.

  PMID: 28135188 BACKGROUND

• Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.

  PMID: 18177778 BACKGROUND

• Fraser WD, Marcoux S, Moutquin JM, Christen A. Effect of early amniotomy on the risk of dystocia in nulliparous women. The Canadian Early Amniotomy Study Group. N Engl J Med. 1993 Apr 22;328(16):1145-9. doi: 10.1056/NEJM199304223281602.

  PMID: 8257472 BACKGROUND

• Gagnon-Gervais K, Bujold E, Iglesias MH, Duperron L, Masse A, Mayrand MH, Sansregret A, Fraser W, Audibert F. Early versus late amniotomy for labour induction: a randomized controlled trial. J Matern Fetal Neonatal Med. 2012 Nov;25(11):2326-9. doi: 10.3109/14767058.2012.695819. Epub 2012 Jun 13.

  PMID: 22616980 BACKGROUND

• 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.

  PMID: 22959833 BACKGROUND

• Onah LN, Dim CC, Nwagha UI, Ozumba BC. Effect of early amniotomy on the outcome of spontaneous labour: a randomized controlled trial of pregnant women in Enugu, South-east Nigeria. Afr Health Sci. 2015 Dec;15(4):1097-103. doi: 10.4314/ahs.v15i4.7.

  PMID: 26958009 BACKGROUND

• 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.

  PMID: 27500341 BACKGROUND

• Parrish MM, Kuper SG, Jauk VC, Baalbaki SH, Tita AT, Harper LM. Does Early Artificial Rupture of Membranes Speed Labor in Preterm Inductions? Am J Perinatol. 2018 Jul;35(8):716-720. doi: 10.1055/s-0037-1612631. Epub 2017 Dec 14.

  PMID: 29241279 BACKGROUND

• 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.

  PMID: 19623003 BACKGROUND

• Kuper SG, Sievert RA, Steele R, Biggio JR, Tita AT, Harper LM. Maternal and Neonatal Outcomes in Indicated Preterm Births Based on the Intended Mode of Delivery. Obstet Gynecol. 2017 Nov;130(5):1143-1151. doi: 10.1097/AOG.0000000000002320.

  PMID: 29016494 BACKGROUND

• Cooney LG, Bastek JA. The Association between Early Artificial Amniotomy and Chorioamnionitis in Nulliparous Induction of Labor. Int Sch Res Notices. 2014 Dec 16;2014:628452. doi: 10.1155/2014/628452. eCollection 2014.

  PMID: 27379338 BACKGROUND

Study Officials

• Lindsay S Robbins, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor-Fellow

Model Details: Participants are assigned to early amniotomy (\<4cm cervical dilation) or late amniotomy (≥4cm dilated). Participants may crossover due due to clinical conditions that are not preventable. These conditions may include: unengaged vertex at time of attempted amniotomy, need for internal monitors, or cervical dilation that does not reach 4cm.

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: November 14, 2018
• Primary Completion: August 26, 2020
• Study Completion: January 13, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

US (1)