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Prolonged PregnancyPhase 3NCT02907060

Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

A Phase 3 study testing Mechanical cervical ripening and Pharmacological cervical ripening in people with Prolonged Pregnancy, run by University Hospital, Tours at 14 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

A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Prolonged Pregnancy
What is being tested?
Mechanical cervical ripening and Pharmacological cervical ripening
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,224 participants
Where
14 sitesFrance
Study dates
27 Jan 2017to 12 Dec 2018
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pregnant women
  • ≥ 18 years old
  • With a singleton cephalic pregnancy between ≥41+0 weeks and ≤ 42+0 weeks of gestation
  • Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation)
  • With a decision of induction of labour
  • Written informed consent obtained from subject
  • Subject covered by or having the rights to the French Social Security system

Who cannot join

  • Bishop score ≥ 6 (favourable cervix)
  • Non cephalic presentation (breech, transverse)
  • Severe preeclampsia defined as the presence of preeclampsia with at least one of the following items :
  • Severe maternal hypertension (systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 110 mm Hg)
  • Renal failure with oliguria (< 500 ml/24h) or creatinine > 135μmol/L, or proteinuria > 5 g/day
  • Pulmonary oedema, epigastric pain or HELLP syndrom (hemolysis, elevated liver enzyme, low platelets)
Show all 18Show fewer
  • Eclampsia or neurologic persisting symptoms (visual disturbances, headache, increased reflexes)
  • Thrombopenia < 100 G/L
  • Prior caesarean section or uterine scar
  • Placenta praevia
  • Suspected genital herpes infection
  • Known VIH seropositivity (confirmed by blood serology)
  • Premature rupture of membranes (PROM - continual leaking of amniotic fluid or positive test in favour of PROM)
  • Foetus with suspected severe congenital abnormalities
  • Pathological fetal heart rate
  • Contra-indications to Propess®
  • Contra-indications for using Cook® Cervical Ripening Balloon
  • Women under guardianship or trusteeship

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Chu Brest

    Brest

  • CHU CAEN

    Caen, 14033

  • Ch Pontoise

    Cergy-Pontoise, 95303

  • Ch Chartres

    Chartres

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63001

  • Ch Departemental Vendee

    La Roche-sur-Yon, 85925

  • Hopital Saint Joseph

    Marseille, 13008

  • Chu Nantes

    Nantes, 44093

  • Chi Poissy

    Poissy

  • Chu Reims

    Reims, 51092

  • Chu Rennes

    Rennes

  • Chu Saint Etienne

    Saint-Priest-en-Jarez, 42270

  • Chu Toulouse

    Toulouse

  • Chru Tours

    Tours, 37044

Other trials in France

About this study

Official title: Propess® Versus Double Balloon for Cervical Ripening of Prolonged Pregnancies: a Randomised Controlled Trial

A pregnancy is considered ''prolonged'' from 41 weeks of gestation. Prolonged Pregnancies (PP) are associated with increased maternal morbidity: emergency caesarean, 3rd and 4th degree perineal lesions and postpartum haemorrhage. Foetuses are at increased risk of oligohydramnios, meconium-staining and Fetal Heart Rate (FHR) anomalies. Around 15% of all pregnancies are prolonged.

A Cochrane review on induction of labour showed that a policy of labour induction at or beyond 41 weeks was associated with significantly fewer perinatal deaths. Thus the French College of Obstetricians and Gynaecologists stated, "induction of labour can be proposed to patients between 41+0 and 41+6 weeks of gestation". In cases where labour is induced and cervix is unfavourable, cervical ripening is advised. Methods of cervical ripening include pharmacological (prostaglandins) and mechanical (Foley catheter or trans-cervical double balloon) methods. Those two methods were compared in the PROBAAT trial among women with term pregnancies (beyond 37+0). The rates of caesarean section with these two strategies were identical, however uterine hyper stimulation with FHR anomalies occurred less when cervical ripening was mechanical.

Read more

Considering pharmacological cervical ripening is associated with more uterine hyper stimulation and more FHR anomalies, it may not be the most appropriate in cases of fragile foetuses that include cases of prolonged pregnancies. Considering prolonged pregnancies are associated with a risk of FHR anomalies and that cervical ripening with a pharmacological method is another factor which increases this risk: women with prolonged pregnancies could benefit from a more "gentle" cervical ripening.

At present, no particular method is recommended in cases of cervical ripening and prolonged pregnancies. We hypothesise that, in cases of prolonged pregnancies, mechanical cervical ripening, with less uterine hyperstimulation and fewer FHR anomalies, could be more appropriate and could reduce the rate of caesarean section for suspicion of fetal distress.

Being tested
Mechanical cervical ripening, Pharmacological cervical ripening
Keywords
prolonged pregnancy, mechanical cervical ripening
Medical subject headings
Pregnancy, Prolonged

What participants receive

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

  • Mechanical cervical ripeningDevice

    The mechanical cervical ripening is a double transcervical balloon. The device used in the study is the Cook® Cervical Ripening Balloon with CE marked (commercialized by the Cook® laboratory, ref JCRBS-184000). It is a silicone double balloon catheter. Maximum balloon inflation is 80 mL/balloon.

    It will be used in accordance with user manual

  • Pharmacological cervical ripeningDrug

    The comparative pharmacological procedure is a vaginal slow releasing system of dinoprostone. The form used in the study is Propess (Ferring pharmaceuticals) containing 10mg of dinoprostone (prostaglandin E2).

    It will be used in accordance with Summary of Product Characteristics

Study groups in NCT02907060
Study groupRoleWhat they receive
Mechanical cervical ripeningExperimentalmechanical cervical ripening with a Cook® Cervical Ripening Balloon
Receives: Device: Mechanical cervical ripening
Pharmacological cervical ripeningActive comparatorpharmacological cervical ripening with a 10mg slow releasing system of Dinoprostone (Propess®)
Receives: Drug: Pharmacological cervical ripening

What is being measured

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

  1. Caesarean section rate for non-reassuring fetal status.

    Indication of the caesarean section will be settled by an adjudication committee at the end of the study

    Measured: Up to 2 days after cervical ripening

Secondary outcomes (21)

  1. Time between cervical ripening and delivery in hours

    Evaluation of time between cervical ripening and delivery in hours

    Measured: Up to 2 days after cervical ripening

  2. Delivery rate after 12 and 24 hours of cervical ripening

    Evaluation of delivery rate after 12 and 24 hours of cervical ripening

    Measured: up to 2 days after cervical ripening

  3. Induction with oxytocin

    yes/no

    Measured: up to 2 days after cervical ripening

  4. Total dose of oxytocin required for induction of labour

    evaluation of total dose of oxytocin required for induction of labour

    Measured: up to 2 days after cervical ripening

  5. Uterine hyper stimulation defined as more than 6 contractions by 10 minutes over a 30 minutes period

    uterine hyperstimulation

    Measured: up to 2 days after cervical ripening

  6. Requirement for tocolysis during cervical ripening or during labour

    requirement for tocolysis

    Measured: up to 2 days after cervical ripening

  7. Suspicious or pathological fetal heart rate

    FIGO classification

    Measured: up to 2 days after cervical ripening

  8. Uterine rupture

    yes/no

    Measured: up to 2 days after cervical ripening

  9. Use of analgesics during labour

    yes/no

    Measured: up to 2 days after cervical ripening

  10. Use of antibiotics during labour

    yes/no

    Measured: up to 2 days after cervical ripening

  11. Indication for caesarean delivery other than non-reassuring FHR

    (failure to progress in first or second stage of labour or maternal indication)

    Measured: up to 2 days after cervical ripening

  12. Type of vaginal delivery

    spontaneous or instrumental, indication for instrumental delivery

    Measured: up to 2 days after cervical ripening

  13. Maternal intra partum infection

    Suspicion of maternal intra partum infection

    Measured: up to 2 days after cervical ripening

  14. Maternal post partum infection

    Suspicion of post partum infection

    Measured: up to 2 days after cervical ripening

  15. Maternal post partum haemorrhage

    Post partum haemorrhage defined as estimated blood loss > 500 cc

    Measured: up to 2 days after cervical ripening

  16. Maternal blood transfusion

    Blood transfusion

    Measured: up to 2 days after cervical ripening

  17. Neonatal apgar score

    Apgar score at 1, 3, 5 and 10 minutes

    Measured: at 1, 3, 5 and 10 minutes after delivery

  18. Neonatal arterial ph

    Arterial pH at delivery

    Measured: at delivery

  19. Intensive care unit for newborn

    Admission in an intensive care unit

    Measured: up to 5 days after cervical ripening

  20. Neonatal respiratory insufficiency

    Respiratory insufficiency with necessity of any respiratory support

    Measured: up to 5 days after cervical ripening

  21. Birth asphyxia

    Birth asphyxia defined as pH<7, Base Excess >12 mmol/l and encephalopathy.

    Measured: up to 5 days after cervical ripening

Timeline

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

  1. First posted20 Sep 2016 (estimated)
  2. Study start27 Jan 2017
  3. Primary completion12 Dec 2018
  4. Study completion12 Dec 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907060
Sponsor's protocol ID
MAGPOP
Status last verified
Dec 2025
First submitted
6 Sep 2016
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Diguisto C, Le Gouge A, Arthuis C, Winer N, Parant O, Poncelet C, Chauleur C, Hannigsberg J, Ducarme G, Gallot D, Gabriel R, Desbriere R, Beucher G, Faraguet C, Isly H, Rozenberg P, Giraudeau B, Perrotin F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial. PLoS Med. 2021 Feb 11;18(2):e1003448. doi: 10.1371/journal.pmed.1003448. eCollection 2021 Feb.

    PubMed 33571294

  • 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

  • Diguisto C, Le Gouge A, Giraudeau B, Perrotin F. Mechanical cervicAl ripeninG for women with PrOlongedPregnancies (MAGPOP): protocol for a randomised controlled trial of a silicone double balloon catheter versus the Propess system for the slow release of dinoprostone for cervical ripening of prolonged pregnancies. BMJ Open. 2017 Sep 14;7(9):e016069. doi: 10.1136/bmjopen-2017-016069.

    PubMed 28912192

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mechanical cervical ripening and Pharmacological cervical ripening in people with Prolonged Pregnancy, run by University Hospital, Tours at 14 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 7 inclusion and 18 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 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?

Caesarean section rate for non-reassuring fetal status. (time frame: Up to 2 days after cervical ripening). 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 NCT02907060, 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 22 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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