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

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.

Conditions

• Induction of Labor

Interventions

DRUG

Administration of Propess

1. History taking and physical examination including cervical length 2. Eligibility assessment 3. Explanation regarding the study protocol 4. Signed informed consent (at VAS\<3) 5. Women agreeing to continued induction of labor 24 hours after insertion of Propess, will be randomized using sealed envelopes to the subsequent method of induction of labor (additional vaginal insert vs. oxytocin infusion with intracervical balloon insertion with 60ml saline). Treatment will be given according to the pre-existing and approved departmental protocol. The protocol for oxytocin infusion is 4 units of Pitocin in 10 cc 0.9% NaCl, infused at a rate of 0.4 ml/hour. Infusion rate will be increased every 20 minutes until 3-4 contractions every 10 minutes are produced. Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum.

DEVICE

balloon

1. History taking and physical examination including cervical length 2. Eligibility assessment 3. Explanation regarding the study protocol 4. Signed informed consent (at VAS\<3) 5. Women agreeing to continued induction of labor 24 hours after insertion of Propess, will be randomized using sealed envelopes to the subsequent method of induction of labor (additional vaginal insert vs. oxytocin infusion with intracervical balloon insertion with 60ml saline). Treatment will be given according to the pre-existing and approved departmental protocol. The protocol for oxytocin infusion is 4 units of Pitocin in 10 cc 0.9% NaCl, infused at a rate of 0.4 ml/hour. Infusion rate will be increased every 20 minutes until 3-4 contractions every 10 minutes are produced. Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum.

DRUG

Intravenous oxytocin infusion

1. History taking and physical examination including cervical length 2. Eligibility assessment 3. Explanation regarding the study protocol 4. Signed informed consent (at VAS\<3) 5. Women agreeing to continued induction of labor 24 hours after insertion of Propess, will be randomized using sealed envelopes to the subsequent method of induction of labor (additional vaginal insert vs. oxytocin infusion with intracervical balloon insertion with 60ml saline). Treatment will be given according to the pre-existing and approved departmental protocol. The protocol for oxytocin infusion is 4 units of Pitocin in 10 cc 0.9% NaCl, infused at a rate of 0.4 ml/hour. Infusion rate will be increased every 20 minutes until 3-4 contractions every 10 minutes are produced. Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center

  lead OTHER_GOV

Principal Investigators

• yariv yogev, professor · Tel Aviv Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2018-04-30

Completion

2018-04-30