Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial (PITA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03504670
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lindsay Speros Robbins, MD, MPH, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Preterm Pregnancy Labor Induction Procedure: Early Amniotomy Procedure: Late Amniotomy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

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).
Procedure: Early Amniotomy
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.

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.
Procedure: Late Amniotomy
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.




Primary Outcome Measures :
  1. 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. ]
    Proportion of women requiring cesarean delivery


Secondary Outcome Measures :
  1. 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. ]
    Time (hours) from the start of induction (initiation of first cervical ripening agent) to delivery (vaginal or cesarean)

  2. 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. ]
    Time (hours) from the start of induction (initiation of first cervical ripening agent) to vaginal delivery only

  3. Composite maternal morbidity [ Time Frame: Measured from start of induction of labor up to 42 days following delivery ]

    Composed of seven outcomes:

    1. chorioamnionitis (defined as maternal fever >100.3 plus maternal tachycardia, fetal tachycardia, purulent amniotic fluid, or fundal tenderness prior to delivery)
    2. endometritis (defined as maternal fever >100.3 at least 12 hours after delivery with fundal tenderness or purulent discharge)
    3. surgical site infection (infection within 30 days at the surgical site including superficial, deep, organ/space infections)
    4. pneumonia (radiologic diagnosis of pneumonia accompanied by clinical signs/symptoms)
    5. urinary tract infection (>100,000 colonies of a single species in urine culture accompanied by clinical signs/symptoms)
    6. postpartum hemorrhage (estimated blood loss >1000 mL)
    7. umbilical cord prolapse

  4. Composite neonatal morbidity [ Time Frame: Measured up to 28 days of life for the newborn ]

    Composed of five outcomes:

    1. perinatal death (death of a fetus during labor or within 28 days of life)
    2. neonatal sepsis (critically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection)
    3. intraventricular hemorrhage (confirmed on ultrasound or MRI)
    4. cord blood acidemia (umbilical artery gas pH <= 7.0 or base excess >= 12)
    5. Apgar <5 at 5 minutes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504670


Contacts
Layout table for location contacts
Contact: Lindsay S Robbins, MD, MPH 205-975-9858 lsrobbins@uabmc.edu
Contact: Lorie M Harper, MD, MCSI 205-934-5611 lmharper@uabmc.edu

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmigham, Women and Infants' Center Recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: Lindsay S Robbins, MD, MPH         
Sub-Investigator: Lorie M Harper, MD, MCSI         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Lindsay S Robbins, MD, MPH University of Alabama at Birmingham

Publications:

Layout table for additonal information
Responsible Party: Lindsay Speros Robbins, MD, MPH, Instructor-Fellow, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03504670     History of Changes
Other Study ID Numbers: UAB_EarlyAROM
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lindsay Speros Robbins, MD, MPH, University of Alabama at Birmingham:
Labor induction
Cesarean delivery
Preterm labor induction
Duration of labor induction

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications