LaborPhase 3NCT01099280
Induction of Labor in Term Premature Rupture of Membranes: A Comparison Between Oxytocin and Dinoprostone Followed Six Hours Later by Oxytocin
A Phase 3 study testing SYNPITAN FORT 5 IU and Propess,SYNPITAN FORT in people with Labor and Induction, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
Prelabor rupture of membranes (PROM) is most commonly defined as rupture of membranes before the onset of labor and occurs in 8% of term pregnancies. A prolonged interval from rupture of membranes to delivery is associated with an increase in the incidence of chorioamnionitis and neonatal sepsis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Induction, PROM (Pregnancy)
- What is being tested?
- SYNPITAN FORT 5 IU and Propess,SYNPITAN FORT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2009to Nov 2010
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a live singleton fetus at term [37-42 weeks of gestation in cephalic presentation
- reactive nonstress test (NST)
- presenting with PROM
- a Bishop score of 5 or less before the onset of labor
- an absence of spontaneous contractions
Who cannot join
- Women in active labor
- previous uterine surgery,
- antepartum hemorrhage,
- chorioamnionitis,
- contraindication to prostaglandin use (bronchial asthma, glaucoma), *contraindication to vaginal delivery,
- multiple pregnancy,
- non-vertex presentation
- major fetal anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırkoy Women and Children Hospital
Istanbul, Yanimahalle, 34142
About this study
Prelabor rupture of membranes (PROM) is most commonly defined as rupture of membranes before the onset of labor and occurs in 8% of term pregnancies. A prolonged interval from rupture of membranes to delivery is associated with an increase in the incidence of chorioamnionitis and neonatal sepsis. The management of the term patients with PROM, especially those with an unfavorable cervix, remains controversial. Management options to choose from are immediate induction of labor versus delayed induction or expectant management. Several reports have detailed an increase in maternal and neonatal morbidity with expectant management, whereas active management leads to a shorter interval from PROM to delivery, reducing the risk of postnatal infections. In addition, active management is preferred by patients.
The investigators know that, neonatal intensive care admission, variable decelerations, and primary cesarean delivery rates are positively correlated with a longer admission-to-labor-onset interval in women with PROM . So, to reduce the induction to delivery times, concurrent oxytocin infusion with dinoprostone vaginal pessary use for labor induction in women with PROM may be beneficial. Several studies have shown shorter induction-to-delivery interval with concurrent oxytocin infusion with prostaglandin agent at initiation of labor . However, in these studies, there is a a paucity information in PROM labor induction. Only one randomized control trial have compared the efficacy of concurrent dinoprostone and oxytocin and oxytocin alone in women with term PROM . This study indicated that concurrent vaginal dinoprostone and intravenous oxytocin conferred no advantage over intravenous oxytocin alone for the outcomes of interest, including length of labor patient satisfaction or risk for cesarean delivery. Unfortunately, this study was limited by small sample size.
The aims of this randomized study was to compare two protocols (oxytocin vs. sustained-release dinoprostone followed six hours later by oxytocin) for induction of labour in women with PROM at term and an unfavorable cervix.
- Conditions
- Labor, Induction, PROM (Pregnancy)
- Being tested
- SYNPITAN FORT 5 IU, Propess,SYNPITAN FORT
- Keywords
- induction of labor in term, premature rupture of membranes, dinoprostone, oxytocin
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNPITAN FORT 5 IUDrug
A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved. Once started, oxytocin infusion was continued to delivery unless otherwise indicated. The pessary has been removed if it was still present 12 h after placement; or if worrisome FHR pattern persisted
Propess,SYNPITAN FORTDrug
a single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved
| Study group | Role | What they receive |
|---|---|---|
| oxytocin group | Experimental | 2 milliunits/min and doubled every 30 minutes to a maximum of 32 milliunits/min or until four contractions in 10 minutes was achieved Receives: Drug: SYNPITAN FORT 5 IU |
| dinoprostone and oxytocin | Experimental | a single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved Receives: Drug: Propess,SYNPITAN FORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number (rate) of women who succeeded in delivering vaginally within 24 h of the initiation of the labor induction protocol
Measured: 24 hours
Secondary outcomes (1)
labor induction-to-delivery interval
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 posted6 Apr 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Military Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099280
- Sponsor's protocol ID
- Gungorduk-08
- Status last verified
- Mar 2010
- First submitted
- 5 Apr 2010
- Last updated
- 11 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labor in Term Premature Rupture of Membranes: A Comparison Between Oxytocin and Dinoprostone Followed Six Hours Later by Oxytocin
- ClinicalTrials.gov ID
- NCT01099280
- Acronym / sponsor ID
- Gungorduk-08
- Conditions
- Labor, Induction, PROM (Pregnancy)
- Keywords
- induction of labor in term, premature rupture of membranes, dinoprostone, oxytocin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Erzincan Military HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Apr 2010 (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.
Prelabor rupture of membranes (PROM) is most commonly defined as rupture of membranes before the onset of labor and occurs in 8% of term pregnancies. A prolonged interval from rupture of membranes to delivery is associated with an increase in the incidence of chorioamnionitis and neonatal sepsis. The management of the term patients with PROM, especially those with an unfavorable cervix, remains controversial. Management options to choose from are immediate induction of labor versus delayed induction or expectant management. Several reports have detailed an increase in maternal and neonatal morbidity with expectant management, whereas active management leads to a shorter interval from PROM to delivery, reducing the risk of postnatal infections. In addition, active management is preferred by patients.
The investigators know that, neonatal intensive care admission, variable decelerations, and primary cesarean delivery rates are positively correlated with a longer admission-to-labor-onset interval in women with PROM . So, to reduce the induction to delivery times, concurrent oxytocin infusion with dinoprostone vaginal pessary use for labor induction in women with PROM may be beneficial. Several studies have shown shorter induction-to-delivery interval with concurrent oxytocin infusion with prostaglandin agent at initiation of labor . However, in these studies, there is a a paucity information in PROM labor induction. Only one randomized control trial have compared the efficacy of concurrent dinoprostone and oxytocin and oxytocin alone in women with term PROM . This study indicated that concurrent vaginal dinoprostone and intravenous oxytocin conferred no advantage over intravenous oxytocin alone for the outcomes of interest, including length of labor patient satisfaction or risk for cesarean delivery. Unfortunately, this study was limited by small sample size.
The aims of this randomized study was to compare two protocols (oxytocin vs. sustained-release dinoprostone followed six hours later by oxytocin) for induction of labour in women with PROM at term and an unfavorable cervix.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin group | Experimental | Drug: SYNPITAN FORT 5 IU2 milliunits/min and doubled every 30 minutes to a maximum of 32 milliunits/min or until four contractions in 10 minutes was achieved |
| dinoprostone and oxytocin | Experimental | Drug: Propess,SYNPITAN FORTa single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with a live singleton fetus at term [37-42 weeks of gestation in cephalic presentation
- reactive nonstress test (NST)
- presenting with PROM
- a Bishop score of 5 or less before the onset of labor
- an absence of spontaneous contractions
Key exclusion criteria (8 listed)
- Women in active labor
- previous uterine surgery,
- antepartum hemorrhage,
- chorioamnionitis,
- contraindication to prostaglandin use (bronchial asthma, glaucoma), *contraindication to vaginal delivery,
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 |
|---|---|---|
| SYNPITAN FORT 5 IUA standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved. Once started, oxytocin infusion was continued to delivery unless otherwise indicated. The pessary has been removed if it was still present 12 h after placement; or if worrisome FHR pattern persisted | Drug | oxytocin group |
| Propess,SYNPITAN FORTa single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved | Drug | dinoprostone and oxytocin |
Primary outcome
the number (rate) of women who succeeded in delivering vaginally within 24 h of the initiation of the labor induction protocol
Time frame: 24 hours
1 secondary outcome
labor induction-to-delivery interval
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SYNPITAN FORT 5 IU and Propess,SYNPITAN FORT in people with Labor and Induction, run by Erzincan Military Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 11 Apr 2011. 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 Turkey (Türkiye). 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number (rate) of women who succeeded in delivering vaginally within 24 h of the initiation of the labor induction protocol (time frame: 24 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 11 Apr 2011.