Cervical RipeningPhase 3NCT00545194
Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
A Phase 3 study testing Prostaglandin E2 in people with Cervical Ripening and Labor, Induced, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of this study is to compare two different preparation Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Ripening, Labor, Induced
- What is being tested?
- Prostaglandin E2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2002to Oct 2004
- 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
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnancy
- cephalic presentation
- gestation of more than 37 Weeks confirmed by ultrasound
- Bishop score less than 7
- Informed consent
Who cannot join
- previous cesarean section (scarred uterus)
- polyhydramnios
- multiple pregnancy
- fetal malformation
Trial locations and contacts
1 site in 1 country.
France1 site
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, 37044
About this study
Official title: Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy
The aim of this study is to compare two different preparation
- Conditions
- Cervical Ripening, Labor, Induced
- Being tested
- Prostaglandin E2
- Keywords
- Prostaglandin E2, Intravaginal gel, Bishop score, Induction of labor, randomized trial, Vaginal insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostaglandin E2Drug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | sustained release preparation of prostaglandin E2 Receives: Drug: Prostaglandin E2 |
| B | Active comparator | short-acting (instant-released) preparation of prostaglandin E2 Receives: Drug: Prostaglandin E2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vaginal deliveries within the 48 hours after cervical ripening
Measured: 48 hours
Secondary outcomes (10)
Proportion of total vaginal deliveries
Measured: 48 hours
Vaginal deliveries at 12 hours, 24 hours and 36 hours
Measured: 48 hours
Number of hyperkinesia with or without fetal heart rate monitoring abnormalities
Measured: 48 hours
Number of hypertonia with or without fetal heart rate monitoring abnormalities
Measured: 48 hours
Apgar score at 5 min less or equal 7
Measured: 48 hours
Apgar score at 10 min less or equal 7
Measured: 48 hours
Arterial pH less or equal 7.20
Measured: 48 hours
Arterial base excess more than 12
Measured: 48 hours
Number of maternal post-partum haemorrhage
Measured: 48 hours
Time to reach 3cm cervical dilatation
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 Oct 2007 (estimated)
- Study startJan 2002
- Primary completionOct 2004
- Study completionOct 2004
Why it stopped: No participants enrolled
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 Cervical RipeningStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Franck Perrotin, MD-PhD, Principal investigator, Tours Universiity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545194
- Sponsor's protocol ID
- PROPESS Study
- Status last verified
- Oct 2007
- First submitted
- 16 Oct 2007
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lyrenas S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78. doi: 10.1111/j.1471-0528.2001.00039.x.
PubMed 11236117Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5. doi: 10.1080/00016340500523685.
PubMed 16553177El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30. doi: 10.1080/01443610600903362.
PubMed 17071427
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy
- ClinicalTrials.gov ID
- NCT00545194
- Acronym / sponsor ID
- PROPESS Study
- Conditions
- Cervical Ripening, Labor, Induced
- Keywords
- Prostaglandin E2, Intravaginal gel, Bishop score, Induction of labor, randomized trial, Vaginal insert
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jan 2002 (actual)
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 17 Oct 2007 (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 aim of this study is to compare two different preparation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Prostaglandin E2sustained release preparation of prostaglandin E2 |
| B | Active comparator | Drug: Prostaglandin E2short-acting (instant-released) preparation of prostaglandin E2 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- singleton pregnancy
- cephalic presentation
- gestation of more than 37 Weeks confirmed by ultrasound
- Bishop score less than 7
- Informed consent
Key exclusion criteria (4 listed)
- previous cesarean section (scarred uterus)
- polyhydramnios
- multiple pregnancy
- fetal malformation
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 |
|---|---|---|
| Prostaglandin E2 | Drug | A, B |
Primary outcome
Percentage of vaginal deliveries within the 48 hours after cervical ripening
Time frame: 48 hours
10 secondary outcomes
Proportion of total vaginal deliveries
Time frame: 48 hours
Vaginal deliveries at 12 hours, 24 hours and 36 hours
Time frame: 48 hours
Number of hyperkinesia with or without fetal heart rate monitoring abnormalities
Time frame: 48 hours
Number of hypertonia with or without fetal heart rate monitoring abnormalities
Time frame: 48 hours
Apgar score at 5 min less or equal 7
Time frame: 48 hours
Apgar score at 10 min less or equal 7
Time frame: 48 hours
Arterial pH less or equal 7.20
Time frame: 48 hours
Arterial base excess more than 12
Time frame: 48 hours
Number of maternal post-partum haemorrhage
Time frame: 48 hours
Time to reach 3cm cervical dilatation
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 11236117Lyrenas S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78. doi: 10.1111/j.1471-0528.2001.00039.x.
- Background: PubMed 16553177Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5. doi: 10.1080/00016340500523685.
- Background: PubMed 17071427El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30. doi: 10.1080/01443610600903362.
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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.
Franck Perrotin, MD-PhD principal investigator
Tours Universiity Hospital
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 Prostaglandin E2 in people with Cervical Ripening and Labor, Induced, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 4 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: withdrawn, as of the sponsor's last update on 4 Sep 2025. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of vaginal deliveries within the 48 hours after cervical ripening (time frame: 48 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 NCT00545194, 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 4 Sep 2025.