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

NCT ID: NCT02684305

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-04-30

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.

Conditions

Induction of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Administration of Propess

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

balloon

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yariv yogev, professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Central Contacts

yariv yogev, professor

Role: CONTACT

yarivy@tlvmc.gov.il

97236925603

Other Identifiers

686-15- TLV

Identifier Type: -

Identifier Source: org_study_id