Labor, Premature
Conditions
Keywords
Pregnancy, labor induction, preterm
Brief summary
To compare the duration of preterm induction of labor in women undergoing early vs. late or no artificial rupture of membranes (AROM). Maternal and neonatal outcomes will also be compared between the two groups.
Detailed description
Women presenting with a preterm singleton pregnancy between 28.0 and 36.6 weeks of gestation with cephalic lie and a medical indication for induction of labor will be approached for this study. The patient/provider must be attempting induction with the goal of vaginal delivery. Women with ruptured membranes, suspected intrauterine infection, prior uterine scar, fetal demise, or a fetal anomaly will be excluded. Women that agree to the study will be randomized to 2 groups: the early amniotomy group and the late amniotomy group. Women in the early amniotomy group will undergo artificial rupture of membranes (AROM) prior to reaching cervical dilation of 4 cm. Women in the late amniotomy group may not undergo AROM until they reach cervical dilation of greater than 4 cm or they have been on an oxytocin drip for greater than 10 hours with no cervical change. It is possible that a woman in the late amniotomy group will not undergo AROM at all. The primary outcome under consideration is time in labor. Secondary outcomes include rates of chorioamnionitis, postpartum endometritis, mode of delivery, and neonatal outcomes.
Interventions
PROCEDUREEarly Artificial rupture of membranes
Women in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible.
PROCEDUREDelayed Artificial rupture of membranes
Women in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Preterm singleton pregnancy between 28.0 and 36.6 completed weeks of gestation * Fetus in the cephalic position * Intent to induce labor for vaginal delivery * If cervical ripening is planned, patient must be enrolled within an hour of initiation of ripening. If no ripening is planned, enrollment must be complete prior to starting induction.
Exclusion criteria
* Preterm premature rupture of membranes (PPROM) * Fever or suspected chorioamnionitis prior to start of IOL * Prior uterine scar * Infection with HIV/Hepatitis B Virus (HBV)/Hepatitis C Virus (HCV) or an active Herpes Simplex Virus (HSV) infection * Intrauterine fetal demise * Major fetal anomaly * Cervical dilation \> 4 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of labor. | Induction of labor until delivery (1 hr - 48 hrs) | The duration of labor begins with administration of the first induction agent (i.e. Cook balloon, Foley catheter, prostaglandins, or oxytocin) and ends with delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Labor Outcomes: Delivery before 24 hours from start of Induction of Labor (IOL) | Induction of labor until delivery (1 hr - 48 hrs) | A dichotomization of duration of labor |
| Labor Outcomes: Duration of the 2nd stage of labor | Induction of labor until delivery (1 hr - 48 hrs) | Defined as time from the first cervical exam with complete dilation and effacement to the time of delivery |
| Maternal Outcome:Cesarean delivery | at delivery | Mode of delivery |
| Maternal/Labor Outcomes: Indication for Cesarean delivery | at delivery | Reason for cesarean delivery |
| Maternal/Labor Outcomes:Operative vaginal delivery | at delivery | Use of either a vacuum device or obstetrical forceps |
| Maternal intrapartum fever or chorioamnionitis | during labor to delivery | Defined as persistent intrapartum fever and/or suspected or confirmed intraamniotic infection (20) |
| Labor Outcomes:Time from completion of cervical ripening to delivery | Induction of labor until delivery (1 hr - 48 hrs) | When the last induction agent is a foley/Cook balloon, or cervidil (dinoprostone), completion of cervical ripening will be defined as the time when the agent is removed. When the last induction agent is misoprostol, completion of cervical ripening will be defined as 4 hours after administration of the last dose. |
| Epidural anesthesia | during labor | Use of epidural regional anesthesia for pain control during induction of labor |
| Recurrent variable or late decelerations | during labor | As defined by The American College of Obstetrics and Gynecology ( ACOG), practice bulletin No 110 |
| Meconium stained amniotic fluid | during labor and delivery | Meconium is noted in the amniotic fluid after rupture of membranes |
| Tachysystole | during labor | As defined by ACOG, practice bulletin No 110 |
| Use of amnioinfusion | during labor | Placement of an intrauterine catheter and infusion of saline into the uterus during induction of labor |
| Use of intrapartum tocolytics | during labor | Administration of a tocolytic drug during labor |
| Post-partum endometritis: | up to 10 days | defined as postpartum febrile morbidity in the absence of another causative factor (i.e. wound infection, deep venous thrombosis). Postpartum febrile morbidity is defined as oral temperature ≥ 38.0⁰ C on any 2 of the first 10 days postpartum, exclusive of the first postpartum day |
Countries
United States
Outcome results
None listed