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

NCT02684305 | Unknown Phase 3 DMC

• 1 other identifier: 686-15- TLV
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

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. 1.During the past years there has been an additional rise due to elective inductions
2. 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.

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

• Time from second agent induction to delivery

  Time from second agent induction to active labor

  48 hours

Secondary Outcomes (3)

• Rate of failed induction defined as 5 cm dilatation

  48 hours

• Rate of failed induction defined as regular contractions

  48 hours

• cesarean sections rate

  48 hours

Study Arms (2)

Administration of Propess

EXPERIMENTAL

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.

Drug: Administration of Propess

Intravenous oxytocin infusion + balloon

EXPERIMENTAL

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.

Device: balloon; Drug: Intravenous oxytocin infusion

Interventions

Administration of Propess DRUG

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.

Administration of Propess

balloon DEVICE

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.

Intravenous oxytocin infusion + balloon

Intravenous oxytocin infusion DRUG

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.

Intravenous oxytocin infusion + balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age of 18 years or greater
• Singleton gestation
• Bishop score of 7 or less 24 hours after the insertion of Propess
• Pregnancies at 36+0/7 weeks of gestation and beyond
• 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)
• No contraindication for prolongation of pregnancy (e.g. intrauterine infection, placental abruption, etc.)

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Officials

• yariv yogev, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yariv yogev, professor

CONTACT

97236925603; yarivy@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 17, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 24, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share