Early Amniotomy, Unfavorable CervixPhase 2PGE2NCT02856724
Early Amniotomy After Vaginal Prostaglandin E2 for Induction of Labor at Term: a Randomized Clinical Trial
A Phase 2 study testing PGE2 in people with Early Amniotomy, Unfavorable Cervix, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Amniotomy, Unfavorable Cervix
- What is being tested?
- PGE2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Oct 2016
- Phase
- Phase 2
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy,
- gestational age ≥34 weeks,
- intact membranes,
- cephalic presentation,
- bishop score ≤5,
- had obstetrical indications for induction of labor,
- had less than three uterine contractions in every 10 minutes.
Who cannot join
- Patients who have contraindications for vaginal delivery,
- previous uterine surgery,
- fetal malpresentation,
- multifetal pregnancy,
- more than three contractions in 10 minutes,
- contraindications to prostaglandins,
Show all 10Show fewer
- a category II or III fetal heart rate pattern,
- anomalous fetus,
- fetal demise
- women with immediate delivery indications -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Woman and Child Diseases Education and Research Hospital
Istanbul, 34000
About this study
This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other half of participants) until the membranes rupture spontaneously.
Read the detailed description
During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is commonly used in combination with induction of labor. However, there is a lack of data on both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin works efficiently in cervical ripening and labor induction. So dinoprostone surely performs quite well in promoting cervical ripening and labor induction since its main component is prostaglandin E2 (PGE2).
- Conditions
- Early Amniotomy, Unfavorable Cervix
- Being tested
- PGE2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGE2Drug
Also called dinoprostone
10 mg PGE2 vaginal ovul(Propess)
| Study group | Role | What they receive |
|---|---|---|
| Early amniotomy and PGE2 | Experimental | 10 mg PGE2 vaginal ovul(Propess) Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook. Receives: Drug: PGE2 |
| PGE2 | Active comparator | 10 mg PGE2 vaginal ovul(Propess) Receives: Drug: PGE2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction-to- delivery time
Measured: delivery (the length of time between the beginning of induction and the end of labor)
Secondary outcomes (2)
mode of labor (vaginal or C-section)
Measured: delivery
successful induction
Measured: vaginal delivery within 24 h from the beginning of induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Early Amniotomy, Unfavorable CervixStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- evrim bostanci ergen, M.D., Study director, Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856724
- Sponsor's protocol ID
- 145
- Acronym
- PGE2
- Status last verified
- Dec 2016
- First submitted
- 2 Aug 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Ozkan S, Caliskan E, Doger E, Yucesoy I, Ozeren S, Vural B. Comparative efficacy and safety of vaginal misoprostol versus dinoprostone vaginal insert in labor induction at term: a randomized trial. Arch Gynecol Obstet. 2009 Jul;280(1):19-24. doi: 10.1007/s00404-008-0843-9. Epub 2008 Nov 26.
PubMed 19034471Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.
PubMed 23926074Makarem MH, Zahran KM, Abdellah MS, Karen MA. Early amniotomy after vaginal misoprostol for induction of labor: a randomized clinical trial. Arch Gynecol Obstet. 2013 Aug;288(2):261-5. doi: 10.1007/s00404-013-2747-6. Epub 2013 Feb 21.
PubMed 23430026
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Amniotomy After Vaginal Prostaglandin E2 for Induction of Labor at Term: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02856724
- Acronym / sponsor ID
- PGE2 / 145
- Conditions
- Early Amniotomy, Unfavorable Cervix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Aug 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.
This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other half of participants) until the membranes rupture spontaneously.
Detailed description
During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is commonly used in combination with induction of labor. However, there is a lack of data on both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin works efficiently in cervical ripening and labor induction. So dinoprostone surely performs quite well in promoting cervical ripening and labor induction since its main component is prostaglandin E2 (PGE2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early amniotomy and PGE2 | Experimental | Drug: PGE210 mg PGE2 vaginal ovul(Propess) Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook. |
| PGE2 | Active comparator | Drug: PGE210 mg PGE2 vaginal ovul(Propess) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- singleton pregnancy,
- gestational age ≥34 weeks,
- intact membranes,
- cephalic presentation,
- bishop score ≤5,
Key exclusion criteria (10 listed)
- Patients who have contraindications for vaginal delivery,
- previous uterine surgery,
- fetal malpresentation,
- multifetal pregnancy,
- more than three contractions in 10 minutes,
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 |
|---|---|---|
| PGE2Also: dinoprostone10 mg PGE2 vaginal ovul(Propess) | Drug | Early amniotomy and PGE2, PGE2 |
Primary outcome
induction-to- delivery time
Time frame: delivery (the length of time between the beginning of induction and the end of labor)
2 secondary outcomes
mode of labor (vaginal or C-section)
Time frame: delivery
successful induction
Time frame: vaginal delivery within 24 h from the beginning of induction
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 8 Dec 2016.
- Background: PubMed 19034471Ozkan S, Caliskan E, Doger E, Yucesoy I, Ozeren S, Vural B. Comparative efficacy and safety of vaginal misoprostol versus dinoprostone vaginal insert in labor induction at term: a randomized trial. Arch Gynecol Obstet. 2009 Jul;280(1):19-24. doi: 10.1007/s00404-008-0843-9. Epub 2008 Nov 26.
- Background: PubMed 23926074Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Cochrane Database Syst Rev. 2013 Aug 7;2013(8):CD006794. doi: 10.1002/14651858.CD006794.pub4.
- Results publication: PubMed 23430026Makarem MH, Zahran KM, Abdellah MS, Karen MA. Early amniotomy after vaginal misoprostol for induction of labor: a randomized clinical trial. Arch Gynecol Obstet. 2013 Aug;288(2):261-5. doi: 10.1007/s00404-013-2747-6. Epub 2013 Feb 21.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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.
evrim bostanci ergen, M.D. study director
Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PGE2 in people with Early Amniotomy, Unfavorable Cervix, run by Zeynep Kamil Maternity and Pediatric Research and Training 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 7 inclusion and 10 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 8 Dec 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
induction-to- delivery time (time frame: delivery (the length of time between the beginning of induction and the end of labor)). 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 NCT02856724, which also lists 3 linked publications.
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 8 Dec 2016.