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

Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02684305
• Other study ID #: 686-15- TLV
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 28, 2016
• Last updated: March 23, 2016
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: yariv yogev, professor
• Phone: 97236925603
• Email: yarivy[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Drug:
• Administration of Propess
History taking and physical examination including cervical length Eligibility assessment Explanation regarding the study protocol Signed informed consent (at VAS<3) 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
History taking and physical examination including cervical length Eligibility assessment Explanation regarding the study protocol Signed informed consent (at VAS<3) 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
History taking and physical examination including cervical length Eligibility assessment Explanation regarding the study protocol Signed informed consent (at VAS<3) 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from second agent induction to delivery	Time from second agent induction to active labor	48 hours	No
Secondary	Rate of failed induction defined as 5 cm dilatation	Defined as 5 cm dilatation with regular contractions	48 hours	No
Secondary	Rate of failed induction defined as regular contractions	Rate of failed induction defined as regular contractions (over 3 contractions in 30 min)	48 hours	No
Secondary	cesarean sections rate	Number of cesarean sections rate due to tachysystole and non-reassuring fetal heart rate.	48 hours	No