Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction

Phase 3

• Conditions: Induction of Labor
• Interventions: Device: balloon; Drug: Administration of Propess; Drug: Intravenous oxytocin infusion

• Registration Number: NCT02684305
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Induction of labor is one of the most common obstetrical medical procedures performed today. Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is undertaken for various maternal and fetal indications and spans 20% of deliveries today.

1. During the past years there has been an additional rise due to elective inductions

2. Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks of induced delivery, particularly those associated with post-term pregnancy, rupture of membranes, oligohydramnios and additional fetal and maternal conditions that pose risks to mother and fetus.

In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less) sequential induction with more than one agent is necessary. To date, no trial has compared the optimal subsequent ripening method after the preliminary use of dinoprostone (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of subsequent induction in women admitted for induction of labor with Bishop score \<7 or less 24 hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine induction of labor will be compared: An additional Propess induction for another 24 hours vs. intravenous oxytocin infusion combined with intra-cervical balloon insertion.

Detailed Description

Induction of labor is one of the most common obstetrical medical procedures performed today. Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is undertaken for various maternal and fetal indications and spans 20% of deliveries today

1. During the past years there has been an additional rise due to elective inductions

2. Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks of induced delivery, particularly those associated with post-term pregnancy, rupture of membranes, oligohydramnios and additional fetal and maternal conditions that pose risks to mother and fetus.

In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less) sequential induction with more than one agent is necessary. To date, no trial has compared the optimal subsequent ripening method after the preliminary use of dinoprostone (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of subsequent induction in women admitted for induction of labor with Bishop score \<7 or less 24 hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine induction of labor will be compared: An additional Propess induction for another 24 hours vs. intravenous oxytocin infusion combined with intra-cervical balloon insertion.

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-17
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24
• Study Start: 2016-04
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

1. Maternal age of 18 years or greater
2. Singleton gestation
3. Bishop score of 7 or less 24 hours after the insertion of Propess
4. Pregnancies at 36+0/7 weeks of gestation and beyond
5. Normal fetal heart rate tracings and normal sonogram at admission (ie Vertex, appropriate for gestational age, biophysical score of 8/8, normal amniotic fluid index)
6. No contraindication for prolongation of pregnancy (e.g. intrauterine infection, placental abruption, etc.)

Exclusion Criteria

1. Situations preventing continuation of induction process in any arm - patient refusal, maternal of fetal conditions necessitating prompt delivery.
2. Rupture of membranes (ROM) after initial Propess insertion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous oxytocin infusion + balloon	Intravenous oxytocin infusion	All women who failed induction of labor using vaginal insert slow release of dinoprostone 10 mg (Propess), defined as bishop score ≤ 7 24 hours after propess insertion will be randomized to one of the following treatment arms: 2. Intravenous oxytocin infusion combined with intracervical balloon administration, inflated with 60cc of saline.
Intravenous oxytocin infusion + balloon	balloon	All women who failed induction of labor using vaginal insert slow release of dinoprostone 10 mg (Propess), defined as bishop score ≤ 7 24 hours after propess insertion will be randomized to one of the following treatment arms: 2. Intravenous oxytocin infusion combined with intracervical balloon administration, inflated with 60cc of saline.
Administration of Propess	Administration of Propess	All women who failed induction of labor using vaginal insert slow release of dinoprostone 10 mg (Propess), defined as bishop score ≤ 7 24 hours after propess insertion will be randomized to one of the following treatment arms: 1.Administration of Propess for additional 24 hours.

Primary Outcome Measures

Name	Time	Method
Time from second agent induction to delivery	48 hours	Time from second agent induction to active labor

Secondary Outcome Measures

Name	Time	Method
Rate of failed induction defined as 5 cm dilatation	48 hours	Defined as 5 cm dilatation with regular contractions
Rate of failed induction defined as regular contractions	48 hours	Rate of failed induction defined as regular contractions (over 3 contractions in 30 min)
cesarean sections rate	48 hours	Number of cesarean sections rate due to tachysystole and non-reassuring fetal heart rate.