- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03504670
Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial (PITA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The rate of preterm birth in the United States is nearly 10%. Up to one-third of these births are the result of a medically-indicated delivery. While induction of labor in women at term gestation has been extensively studied, the same is not true for preterm gestations. Consequently, the same methods of labor induction are used in term and preterm gestations, although preterm gestations may have different responses to induction agents compared to term gestations.
At our institution, a standard induction of labor - for term or preterm women - is performed using a cervical Foley catheter or misoprostol for cervical ripening with the addition of intravenous oxytocin for labor augmentation. As membranes do not typically spontaneously rupture during the induction process, amniotomy is commonly utilized by providers to help augment labor. Amniotomy releases prostaglandin-rich amniotic fluid. These prostaglandins are important mediators of uterine contractility and ultimately active labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients.
The timing of amniotomy is left up to the discretion of the treating providers, as there are no randomized controlled trials to support early versus late amniotomy at preterm gestations. However, a retrospective cohort of nulliparous and multiparous women at our institution undergoing induction at 23-34 weeks, and evaluating early amniotomy at <4cm cervical dilation versus late amniotomy at ≥4cm dilation, showed an increased risk of cesarean delivery and increased time from start of induction to delivery for early amniotomy, although only the cesarean delivery outcome was significant after adjusting for confounders.
We will conduct an intention-to-treat randomized controlled 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 attending obstetrician has decided to induce labor for a medical indication. Early amniotomy will be performed prior to 4cm cervical dilation being reached. Late amniotomy will be performed at greater than or equal to 4cm cervical dilation.
The purpose of this study is to determine whether timing of amniotomy during medically-indicated preterm induction of labor affects labor outcomes. We will specifically be looking at risk of cesarean delivery, duration of labor, maternal morbidity, and neonatal morbidity. We hypothesize that more women in the early amniotomy group will require cesarean delivery and that the duration of labor will increase in the early amniotomy group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmigham, Women and Infants' Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
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 |
---|---|
Experimental: Early amniotomy
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).
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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.
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Experimental: Late amniotomy
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cesarean delivery
Time Frame: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
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Proportion of women requiring cesarean delivery
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Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interval from induction onset to delivery
Time Frame: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
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Time (hours) from the start of induction (initiation of first cervical ripening agent) to delivery (vaginal or cesarean)
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Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
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Interval from induction onset to vaginal delivery
Time Frame: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
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Time (hours) from the start of induction (initiation of first cervical ripening agent) to vaginal delivery only
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Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
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Composite maternal morbidity
Time Frame: Measured from start of induction of labor up to 42 days following delivery
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Composed of seven outcomes:
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Measured from start of induction of labor up to 42 days following delivery
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Composite neonatal morbidity
Time Frame: Measured up to 28 days of life for the newborn
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Composed of five outcomes:
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Measured up to 28 days of life for the newborn
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Collaborators and Investigators
Investigators
- Principal Investigator: Lindsay S Robbins, MD, MPH, University of Alabama at Birmingham
Publications and helpful links
General Publications
- Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
- UAB_EarlyAROM
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
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