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

T

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)

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

Trial contacts and locations

0

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Central trial contact

yariv yogev, professor

Data sourced from clinicaltrials.gov

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