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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 3

Conditions: Induction of Labor

Treatments: Drug: Administration of Propess; Drug: Intravenous oxytocin infusion; Device: balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02684305

686-15- TLV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Administration of Propess

Experimental group

Description:

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.

Treatment:

Drug: Administration of Propess

Intravenous oxytocin infusion + balloon

Experimental group

Description:

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.

Treatment:

Device: balloon

Drug: Intravenous oxytocin infusion