ObesityPhase 2/3NCT02223949
Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods
A Phase 2/3 study testing Cook double balloon catheter and PGE1 tablet in people with Obesity and Labor Complications, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity, Labor Complications
- What is being tested?
- Cook double balloon catheter and PGE1 tablet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Nov 2016
- Phase
- Phase 2/3
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 years of age or older.
- Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy.
- Having a Bishop score of 4 points or less.
- Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction.
- Willingness to comply with the protocol for the duration of the study.
- Has agreed and signed an informed consent after given oral and written explanation.
Who cannot join
- Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr).
- Ruptured membranes.
- Previous cesarian section or presence of any uterine scar.
- Documented labor with four or more spontanous uterine contractions per hour.
- Suspected fetal distress necessitating immediate intervention.
- Proven malignancy of the cervix.
Show all 9Show fewer
- Active vaginal bleeding.
- Active inflammatory or purulent condition of the lower genital tract.
- Active asthma.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 169
Saja Murra Anobosy, MD, +972 50 9260067, saja83@gmail.com
About this study
Official title: Labor Induction and Maternal BMI: Comparison of Different Pre-induction Cervical Ripening Methods: The Cook Double Balloon Catheter vs PGE1 Tablets in Lean, Overweight, and Obese Women. A Prospective Randomized Study.
The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.
- Conditions
- Obesity, Labor Complications
- Being tested
- Cook double balloon catheter, PGE1 tablet
- Keywords
- Obesity, Labor complications, Induction of labor, Mechanical cervical ripening
- Medical subject headings
- Obesity, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook double balloon catheterDevice
PGE1 tabletDrug
Also called Prostaglandin E1
| Study group | Role | What they receive |
|---|---|---|
| Cook double balloon catheter | Experimental | Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed. Receives: Device: Cook double balloon catheter |
| PGE1 tablet insertion | Active comparator | Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours. Receives: Drug: PGE1 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarian section rate
Measured: 24 hours
Secondary outcomes (12)
Incidence of excessive uterine activity Incidence of excessive uterine activity
At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration.
Measured: 24 hours
Active labor onset
Measured: 24 hours
Proportion of vaginal delivery
Measured: 24 hours
Treatment failure
Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening
Measured: 12-24 hours
The ripening-to-delivery time interval
Measured: 24 hours
Need for oxytocin induction and/or augmentation of labor
Measured: 24 hours
Mode of delivery
NVD vs. instrumental
Measured: 24 hours
Intra-partum or postpartum fever
Measured: 48 hours
Incidence of meconium staining
Measured: 24 hours
The proportion of neonates with 5-minute Apgar scores of less than 7
Measured: 48 hours
The number of neonates who were admitted to the neonatal intensive care unit
Measured: 48 hours
morbidity and mortality
Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis).
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 posted22 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Saja Murra Anabosy, MD, Principal investigator, Hillel Yaffe Medical CenterAsnat Walfisch, MD, Study chair, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223949
- Sponsor's protocol ID
- 0033-14-HYMC
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Induction and Maternal BMI: Comparison of Different Pre-induction Cervical Ripening Methods: The Cook Double Balloon Catheter vs PGE1 Tablets in Lean, Overweight, and Obese Women. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT02223949
- Acronym / sponsor ID
- 0033-14-HYMC
- Conditions
- Obesity, Labor Complications
- Keywords
- Obesity, Labor complications, Induction of labor, Mechanical cervical ripening
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 22 Aug 2014 (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.
The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cook double balloon catheter | Experimental | Device: Cook double balloon catheterInsertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed. |
| PGE1 tablet insertion | Active comparator | Drug: PGE1 tabletInsertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 years of age or older.
- Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy.
- Having a Bishop score of 4 points or less.
- Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction.
- Willingness to comply with the protocol for the duration of the study.
Key exclusion criteria (9 listed)
- Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr).
- Ruptured membranes.
- Previous cesarian section or presence of any uterine scar.
- Documented labor with four or more spontanous uterine contractions per hour.
- Suspected fetal distress necessitating immediate intervention.
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 |
|---|---|---|
| Cook double balloon catheter | Device | Cook double balloon catheter |
| PGE1 tabletAlso: Prostaglandin E1 | Drug | PGE1 tablet insertion |
Primary outcome
Cesarian section rate
Time frame: 24 hours
12 secondary outcomes
Incidence of excessive uterine activity Incidence of excessive uterine activity
Time frame: 24 hours
Active labor onset
Time frame: 24 hours
Proportion of vaginal delivery
Time frame: 24 hours
Treatment failure
Time frame: 12-24 hours
The ripening-to-delivery time interval
Time frame: 24 hours
Need for oxytocin induction and/or augmentation of labor
Time frame: 24 hours
Mode of delivery
Time frame: 24 hours
Intra-partum or postpartum fever
Time frame: 48 hours
Incidence of meconium staining
Time frame: 24 hours
The proportion of neonates with 5-minute Apgar scores of less than 7
Time frame: 48 hours
The number of neonates who were admitted to the neonatal intensive care unit
Time frame: 48 hours
morbidity and mortality
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 22 Aug 2014.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
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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.
Saja Murra Anabosy, MD principal investigator
Hillel Yaffe Medical Center
Asnat Walfisch, MD study chair
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cook double balloon catheter and PGE1 tablet in people with Obesity and Labor Complications, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 9 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 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Saja Murra Anabosy, MD (+972 50 9260067, saja83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarian section rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223949, which also lists 1 linked publication.
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 22 Aug 2014.