Prolonged PregnancyPhase 3NOCETERNCT00930618
Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies
A Phase 3 study testing IMN in people with Prolonged Pregnancy and Nulliparity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolonged Pregnancy, Nulliparity
- What is being tested?
- IMN
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,409 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Apr 2014
- 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
- Age > or = 18 years old
- TAS > or = 95 mmHg
- Singleton
- Nulliparity
- Term > or = 41 weeks + 0 day
- Bishop score < or = 5
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- Vertex presentation
- Intact membranes
- No contra-indications of the study treatment
- No maternal or fetal diseases which could indicate immediate labor induction
- Written informed consent
Who cannot join
- Multiple pregnancy
- Multiparity
- Term < 41 weeks
- Bishop score > 5
- Breech presentation
- Rupture of the membranes
Show all 11Show fewer
- Previous cesarean
- Indication to immediate labor induction
- Contraindications to isosorbide mononitrate
- No co-administration of antihypertensive drugs
- No social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors
The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.
Read the detailed description
The purpose of this trial is to determine whether cervical ripening with 40 mg of isosorbide mononitrate given intravaginally at 41+0, 41+2 and 41+4 weeks reduce cesarean section in nullipara with post term pregnancies. Treatments will be administered by midwifes in the maternity wards, women will be allowed to go back home in case of Bishop score<6. Otherwise labor will be induced with oxytocin. If undelivered at 41+5, women with Bishop score<6 will be induced with prostaglandins according to local protocols.
- Conditions
- Prolonged Pregnancy, Nulliparity
- Being tested
- IMN, Placebo
- Keywords
- Prolonged pregnancy, Nulliparity, Cervical ripening, Induced labor, Cesarean section
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMNDrug
Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations
PlaceboDrug
Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration
| Study group | Role | What they receive |
|---|---|---|
| IMN | Experimental | Isosorbide mononitrate Receives: Drug: IMN |
| Placebo | Placebo comparator | Administration of placebo of IMN Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cesarean sections
Measured: 10 days
Secondary outcomes (11)
Number of labor inductions
Measured: 10 days
Number of spontaneous labors
Measured: 10 days
Cesarean for failed labor induction
Measured: 10 days
Cesarean for FHR abnormalities
Measured: 10 days
Cesarean for arrested labor
Measured: 10 days
Mean time between randomisation and spontaneous labor
Measured: 10 days
Isosorbide mononitrate adverse effects
Measured: 10 days
Maternal satisfaction
Measured: 10 days
Neonatal morbidity
Measured: 10 days
Mean time between randomisation and delivery
Measured: 10 days
Mean duration of labor
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- François Goffinet, MD, PhD, Study director, Scientific Responsible
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930618
- Sponsor's protocol ID
- P071212
- Acronym
- NOCETER
- Status last verified
- Nov 2025
- First submitted
- 29 Jun 2009
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schmitz T, Fuchs F, Closset E, Rozenberg P, Winer N, Perrotin F, Verspyck E, Azria E, Carbonne B, Lepercq J, Maillard F, Goffinet F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1089-1097. doi: 10.1097/AOG.0000000000000544.
PubMed 25415159
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors
- ClinicalTrials.gov ID
- NCT00930618
- Acronym / sponsor ID
- NOCETER / P071212
- Conditions
- Prolonged Pregnancy, Nulliparity
- Keywords
- Prolonged pregnancy, Nulliparity, Cervical ripening, Induced labor, Cesarean section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,409 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jun 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Jun 2009 (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 purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.
Detailed description
The purpose of this trial is to determine whether cervical ripening with 40 mg of isosorbide mononitrate given intravaginally at 41+0, 41+2 and 41+4 weeks reduce cesarean section in nullipara with post term pregnancies. Treatments will be administered by midwifes in the maternity wards, women will be allowed to go back home in case of Bishop score<6. Otherwise labor will be induced with oxytocin. If undelivered at 41+5, women with Bishop score<6 will be induced with prostaglandins according to local protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMN | Experimental | Drug: IMNIsosorbide mononitrate |
| Placebo | Placebo comparator | Drug: PlaceboAdministration of placebo of IMN |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > or = 18 years old
- TAS > or = 95 mmHg
- Singleton
- Nulliparity
- Term > or = 41 weeks + 0 day
Key exclusion criteria (11 listed)
- Multiple pregnancy
- Multiparity
- Term < 41 weeks
- Bishop score > 5
- Breech presentation
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 |
|---|---|---|
| IMNAdministration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations | Drug | IMN |
| PlaceboAdministration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration | Drug | Placebo |
Primary outcome
Number of cesarean sections
Time frame: 10 days
11 secondary outcomes
Number of labor inductions
Time frame: 10 days
Number of spontaneous labors
Time frame: 10 days
Cesarean for failed labor induction
Time frame: 10 days
Cesarean for FHR abnormalities
Time frame: 10 days
Cesarean for arrested labor
Time frame: 10 days
Mean time between randomisation and spontaneous labor
Time frame: 10 days
Isosorbide mononitrate adverse effects
Time frame: 10 days
Maternal satisfaction
Time frame: 10 days
Neonatal morbidity
Time frame: 10 days
Mean time between randomisation and delivery
Time frame: 10 days
Mean duration of labor
Time frame: 10 days
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 1 Dec 2025.
- Results publication: PubMed 25415159Schmitz T, Fuchs F, Closset E, Rozenberg P, Winer N, Perrotin F, Verspyck E, Azria E, Carbonne B, Lepercq J, Maillard F, Goffinet F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1089-1097. doi: 10.1097/AOG.0000000000000544.
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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.
François Goffinet, MD, PhD study director
Scientific Responsible
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 IMN in people with Prolonged Pregnancy and Nulliparity, run by Assistance Publique - Hôpitaux de Paris 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 11 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 1 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 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. Some participants in this study may receive a placebo. 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?
Number of cesarean sections (time frame: 10 days). 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 NCT00930618, which also lists 1 linked publication.
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 1 Dec 2025.