Clinical trial NCT02684305: Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction
Official title: Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Induction of Labor
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-02-17
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time from second agent induction to delivery
timeFrame: 48 hours
Secondary outcomes:
measure: Rate of failed induction defined as 5 cm dilatation
timeFrame: 48 hours
measure: Rate of failed induction defined as regular contractions
timeFrame: 48 hours
measure: cesarean sections rate
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: yariv yogev, professor
role: PRINCIPAL_INVESTIGATOR
References: