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

Completed · Not applicable

Conditions studied: Preterm Pregnancy, Labor Induction

In brief

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.

Key facts

Study ID

NCT03504670

Run by

University of Alabama at Birmingham

People needed

86

Starts

2018-11-14

Expected to finish

2021-01-13

Last updated by the study team

2021-04-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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)

Where it is running

• University of Alabama at Birmigham, Women and Infants' Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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