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Delivery UterinePhase 2CYTOPRONCT01765881

Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2

A Phase 2 study testing Misoprostol and Dinoprostone in people with Delivery Uterine, run by University Hospital, Toulouse at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

For about 10% of pregnancies, it is necessary to induce delivery for medical reasons. Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In France, dinoprostone is the own approved medication. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Delivery Uterine
What is being tested?
Misoprostol and Dinoprostone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,700 participants
Where
4 sitesFrance
Study dates
Sep 2012to Sep 2015
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • singleton pregnancy
  • Cephalic presentation
  • Bishop ≤ 5
  • ≤ 3 uterine contractions / 10 mn
  • ≥ 36 weeks gestation
  • Personally signed and dated informed consent document

Who cannot join

  • History of cesarian-section
  • uterine scar
  • deceleration on Cardiotocogram (CTG)
  • placenta praevia
  • bleeding
  • chorioamnionitis
Show all 11Show fewer
  • Fetal weight US ≥4500 g
  • Contra-indication to vaginal delivery
  • Hystory of myomectomy
  • Herpes primoinfection or recurrence
  • Allergy to prostaglandins

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Bicêtre Hospital

    Le Kremlin-Bicêtre, 94000

  • Hospital Poissy

    Poissy, 78303

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • University Hospital Toulouse

    Toulouse, France, 31059

Other trials in France

About this study

Official title: Comparison Between 25 µg Vaginal Misoprostol Versus Slow Release Pessary Prostaglandin-E2 (PGE2) : Could we Use Low Dose Vaginal Misoprostol as a First Line Treatment for Induction of Labor ?

For about 10% of pregnancies, it is necessary to induce delivery for medical reasons. Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In France, dinoprostone is the own approved medication. It is in the form of gel or sustained release device whose effectiveness and side effects are comparable. The vaginal misoprostol has no marketing authorization in France, but is sometimes used. Some data in the scientific literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more complications, was at least as effective and seems to be cost-effective compared with dinoprostone. Misoprostol with this dose and route of administration is now recommended by the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on induction of labor). According to HAS, the investigators still lack data on large samples to confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of cesarean section, and lower cost compared to dinoprostone.

The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs. dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5% difference.

Read the detailed description

To show if the experimental treatment (25μg of intravaginal misoprostol) used for induction of labor in singleton women ≥ 36 weeks gestation with an unfavorable cervix is not clinically and statistically inferior than the reference treatment , ie intravaginal dinoprostone sustained release (10mg), in terms of cesarian sectionto compare the cost-effectiveness and to assess the differential tolerance of the two strategies.

Non-inferiority will be demonstrated if the upper limit of the 90%-bilateral confidence interval of the difference between cesarian section rates (misoprostol - dinosprostone) is below 5% in the intention-to-treat analysis and the per-protocol analysis.

If non-inferiority is demonstrated, as a secondary analysis, superiority of misosprostol will be tested.

Orther secondary objectives are to assess the cost-effectiveness, the tolerance, maternal satisfaction and other efficacy endpoints of the two strategies.

Being tested
Misoprostol, Dinoprostone
Keywords
Induction of labor, cervical ripening, misoprostol,, prostaglandin, cost-effectiveness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MisoprostolDrug

    Also called CYTOTEC, 25 micrograms Misoprostol capsule by intravaginal route

    administration of Misoprostol 25 micrograms capsule by intravaginal route every 4 hours, up to 4 capsules

  • DinoprostoneDrug

    Also called PROPESS, one intravaginal sustained released capsule of 10 milligrams

    administration of one sustained released pessary of 10 milligrams by intravaginal route

Study groups in NCT01765881
Study groupRoleWhat they receive
MisoprostolExperimentalone 25 micrograms capsule all 4 hours by intravaginal route
Receives: Drug: Misoprostol
DinoprostoneActive comparatorone unique intravaginal sustained released of 10 milligrams
Receives: Drug: Dinoprostone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cesarean for all indications

    Occurrence of cesarean section for all indications

    Measured: Up to delivery

Secondary outcomes (1)

  1. Cost-effectiveness of two strategies (direct medical cost differential efficiency strategies measured by the Cesarean rate

    Measured: Up to discharge / end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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
1,700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01765881
Sponsor's protocol ID
1014301
Other IDs
2011-000933-35
Acronym
CYTOPRO
Status last verified
Mar 2016
First submitted
8 Jan 2013
Last updated
28 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mounie M, Costa N, Gaudineau A, Molinier L, Vayssiere C, Derumeaux H. Cost-effectiveness analysis of vaginal misoprostol versus dinoprostone pessary: A non-inferiority large randomized controlled trial in France. Int J Gynaecol Obstet. 2022 Aug;158(2):390-397. doi: 10.1002/ijgo.13999. Epub 2021 Nov 19.

    PubMed 34714938

  • Gaudineau A, Senat MV, Ehlinger V, Gallini A, Morin M, Olivier P, Roth E, Orusco E, Javoise S, Fort J, Lavergne C, Arnaud C, Rozenberg P, Vayssiere C; Groupe de Recherche en Obstetrique rt Gynecologie. Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial. Am J Obstet Gynecol. 2021 Nov;225(5):542.e1-542.e8. doi: 10.1016/j.ajog.2021.04.226. Epub 2021 Apr 19.

    PubMed 33887241

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Misoprostol and Dinoprostone in people with Delivery Uterine, run by University Hospital, Toulouse at 4 sites 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 6 inclusion and 11 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 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?

Cesarean for all indications (time frame: Up to delivery). 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 NCT01765881, which also lists 2 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 28 Apr 2016.

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