Induction of LaborPhase 3NCT02684305
Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction
A Phase 3 study testing Administration of Propess, balloon and Intravenous oxytocin infusion in people with Induction of Labor, run by Tel-Aviv Sourasky Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Administration of Propess, balloon and Intravenous oxytocin infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Maternal age of 18 years or greater
- Singleton gestation
- Bishop score of 7 or less 24 hours after the insertion of Propess
- Pregnancies at 36+0/7 weeks of gestation and beyond
- 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)
- No contraindication for prolongation of pregnancy (e.g. intrauterine infection, placental abruption, etc.)
Who cannot join
- Situations preventing continuation of induction process in any arm - patient refusal, maternal of fetal conditions necessitating prompt delivery.
- Rupture of membranes (ROM) after initial Propess insertion.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- During the past years there has been an additional rise due to elective inductions
- 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.
Read the 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
- During the past years there has been an additional rise due to elective inductions
- 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
- Being tested
- Administration of Propess, balloon, Intravenous oxytocin infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of PropessDrug
- 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.
balloonDevice
- 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.
Intravenous oxytocin infusionDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Administration of Propess | Experimental | 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. Receives: Drug: Administration of Propess |
| Intravenous oxytocin infusion + balloon | Experimental | 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. Receives: Device: balloon; Drug: Intravenous oxytocin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from second agent induction to delivery
Time from second agent induction to active labor
Measured: 48 hours
Secondary outcomes (3)
Rate of failed induction defined as 5 cm dilatation
Defined as 5 cm dilatation with regular contractions
Measured: 48 hours
Rate of failed induction defined as regular contractions
Rate of failed induction defined as regular contractions (over 3 contractions in 30 min)
Measured: 48 hours
cesarean sections rate
Number of cesarean sections rate due to tachysystole and non-reassuring fetal heart rate.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- yariv yogev, professor, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684305
- Sponsor's protocol ID
- 686-15- TLV
- Status last verified
- Mar 2016
- First submitted
- 28 Jan 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction
- ClinicalTrials.gov ID
- NCT02684305
- Acronym / sponsor ID
- 686-15- TLV
- Conditions
- Induction of Labor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- During the past years there has been an additional rise due to elective inductions
- 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
- During the past years there has been an additional rise due to elective inductions
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of Propess | Experimental | Drug: Administration of PropessAll 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. |
| Intravenous oxytocin infusion + balloon | Experimental | Device: balloon, Drug: Intravenous oxytocin infusionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Maternal age of 18 years or greater
- Singleton gestation
- Bishop score of 7 or less 24 hours after the insertion of Propess
- Pregnancies at 36+0/7 weeks of gestation and beyond
- 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)
Key exclusion criteria (2 listed)
- Situations preventing continuation of induction process in any arm - patient refusal, maternal of fetal conditions necessitating prompt delivery.
- Rupture of membranes (ROM) after initial Propess insertion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of Propess1. 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. | Drug | Administration of Propess |
| balloon1. 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. | Device | Intravenous oxytocin infusion + balloon |
| Intravenous oxytocin infusion1. 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. | Drug | Intravenous oxytocin infusion + balloon |
Primary outcome
Time from second agent induction to delivery
Time frame: 48 hours
Time from second agent induction to active labor
3 secondary outcomes
Rate of failed induction defined as 5 cm dilatation
Time frame: 48 hours
Rate of failed induction defined as regular contractions
Time frame: 48 hours
cesarean sections rate
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yariv yogev, professor principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Administration of Propess, balloon and Intravenous oxytocin infusion in people with Induction of Labor, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yariv yogev, professor (97236925603, yarivy@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from second agent induction to delivery (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.