Preterm Premature Rupture of MembranePhase 3TOCOPROMNCT03976063
Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation
A Phase 3 study testing Nifedipine in people with Preterm Premature Rupture of Membrane, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Premature Rupture of Membrane
- What is being tested?
- Nifedipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 857 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2019to Nov 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of gestation, as diagnosed by obstetric team
- Singleton gestation
- Fetus alive at the time of randomization (reassuring fetal heart monitoring)
- 18 years of age or older
- French speaking
- Affiliated to social security regime or an equivalent system
- Informed consent and signed
Who cannot join
- PPROM ≥ 24 hours before diagnosis
- Ongoing tocolytic treatment at the time of PPROM
- Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization
- Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
- Cervical dilation > 5 cm
- Iatrogenic rupture caused by amniocentesis or trophoblast biopsy
Show all 17Show fewer
- Major fetal anomaly
- Maternal allergy or contra-indication to Nifedipine or placebo drug components*:
- Myocardial infarction
- Unstable angina pectoris
- Hepatic insufficiency
- Cardiovascular shock
- Beta blockers
- placebo drug components: lactose monohydrate, colloidal silica, microcrystalline cellulose
- Coadministration of diltiazem or rifampicin
- Hypotension (systolic pressure < 90 mmHg)
- Participation to another interventional research (category 1) in which intervention could interfere with TOCOPROM's results (efficacy and safety)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
Read the detailed description
Preterm premature rupture of membranes (PPROM) complicates 3% of pregnancies and accounts for one-third of preterm births. It is a leading cause of neonatal mortality and morbidity and increases the risk of maternal infectious morbidity. In cases of early PPROM (22 to 33 completed weeks' gestation), expectant management is recommended in the absence of labor, chorioamnionitis or fetal distress. Antenatal steroids and antibiotics administration are recommended by international guidelines. However, there is no recommendation regarding tocolysis administration in the setting of PPROM. In theory, reducing uterine contractility should delay delivery and reduce risks of prematurity and neonatal adverse consequences. Likewise, a prolongation of gestation may allow administering a corticosteroids complete course that is associated with a two-fold reduction of morbidity and mortality. However, tocolysis may prolong fetal exposure to inflammation and be associated with higher risk of materno-fetal infection, potentially associated with neonatal death or long-term sequelae, including cerebral palsy.
The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
- Conditions
- Preterm Premature Rupture of Membrane
- Being tested
- Nifedipine, Placebo of Nifedipine
- Keywords
- Preterm premature rupture of membranes, Tocolysis, Nifedipine, Latency, Neonatal outcome, Preterm birth, Randomized controlled trial
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifedipineDrug
Loading dose: Oral Nifedipine 20 mg prolonged-release at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg prolonged-release at T3, then 1 pill every 8 hr for 48 hr (i.e. T11, T19, T27, T35 and T43, total=6x20 mg)
Placebo of NifedipineDrug
Oral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Active comparator | Not described Receives: Drug: Nifedipine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo of Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal morti-morbidity
Composite outcome including fetal death, neonatal death and/or neonatal severe morbidity (mechanical ventilation ≥ 48 hrs, severe bronchopulmonary dysplasia, severe intraventricular hemorrhage, cystic periventricular leucomalacia, neonatal early-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity).
Measured: Up to discharge from hospital, with a maximum of 24 weeks after birth.
Secondary outcomes (25)
Prolongation of gestation
Latency duration (defined as the duration from PPROM to delivery)
Measured: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Prolongation of gestation
Pregnancy prolongation beyond 48 hours after randomization
Measured: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Prolongation of gestation
Pregnancy prolongation beyond 1 week after randomization
Measured: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Prolongation of gestation
Gestational age at delivery
Measured: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Prolongation of gestation
Delivery after 37 weeks of gestation
Measured: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Maternal morbidity
Endometritis, based on clinical diagnosis associating fever (temperature ≥ 38.0°C) with uterine tenderness, purulent or foul-smelling lochia, and in the absence of any other cause.
Measured: During the first 10 days postpartum
Maternal morbidity
Intra-uterine infection, defined as fever (maternal temperature ≥38 °C), with no alternative cause identified, associated with at least two of the following criteria: persistent fetal tachycardia > 160 bpm, uterine pain or painful uterine contractions or spontaneous labor, purulent amniotic fluid.
Measured: At delivery
Fetal mortality
Fetal death
Measured: Up to delivery so up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Neonatal mortality
Neonatal death
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Mechanical ventilation ≥ 48 hrs
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Severe bronchopulmonary dysplasia
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Severe intraventricular hemorrhage
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Cystic periventricular leucomalacia
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Early-onset sepsis
Measured: From birth to Day 3 after birth.
Neonatal severe morbidity
Necrotizing enterocolitis
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Retinopathy of prematurity
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal morbidity
Severe fetal acidemia
Measured: At birth.
Neonatal morbidity
Respiratory distress syndrome
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal morbidity
Mild or moderate bronchopulmonary dysplasia
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal morbidity
Grades I-II intraventricular hemorrhage
Measured: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal morbidity
Late-onset sepsis.
Measured: From Day 3 after birth to discharge from hospital, with a maximum of 24 weeks after birth.
Vital status
Death between discharge and follow up at 2 years
Measured: At 22-26 months of corrected age
Frequency of Gross motor impairment among children alive at 2 years of corrected age
Cerebral palsy
Measured: At 22-26 months of corrected age
Frequency of Neurosensory impairment among children alive at 2 years of corrected age
Visual impairment
Measured: At 22-26 months of corrected age
Frequency of Neurosensory impairment among children alive at 2 years of corrected age
Hearing impairment
Measured: At 22-26 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start7 Oct 2019
- Primary completionNov 2026 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Preterm Premature Rupture of MembraneStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 857 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France, Groupe de Recherche en Obstétrique et Gynécologie, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Gilles Kayem, MD, PhD, Principal investigator, INSERM UMR 1153, Obstetrical, Perinatal and PEdiatric Epidemiology (EPOPé) Research Team, Center of Research in Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University, Trousseau University HospitalElsa Lorthe, RM, PhD, Study director, INSERM UMR 1153, Obstetrical, Perinatal and PEdiatric Epidemiology (EPOPé) Research Team, Center of Research in Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976063
- Sponsor's protocol ID
- P160917
- Acronym
- TOCOPROM
- Status last verified
- Apr 2026
- First submitted
- 29 May 2019
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mackeen AD, Seibel-Seamon J, Muhammad J, Baxter JK, Berghella V. Tocolytics for preterm premature rupture of membranes. Cochrane Database Syst Rev. 2014 Feb 27;2014(2):CD007062. doi: 10.1002/14651858.CD007062.pub3.
PubMed 24578236Lorthe E, Goffinet F, Marret S, Vayssiere C, Flamant C, Quere M, Benhammou V, Ancel PY, Kayem G. Tocolysis after preterm premature rupture of membranes and neonatal outcome: a propensity-score analysis. Am J Obstet Gynecol. 2017 Aug;217(2):212.e1-212.e12. doi: 10.1016/j.ajog.2017.04.015. Epub 2017 Apr 13.
PubMed 28412086Couteau C, Haumonte JB, Bretelle F, Capelle M, D'Ercole C. [Management of preterm and prelabour rupture of membranes in France]. J Gynecol Obstet Biol Reprod (Paris). 2013 Feb;42(1):21-8. doi: 10.1016/j.jgyn.2012.10.008. Epub 2012 Nov 24. French.
PubMed 23182704Schmitz T, Sentilhes L, Lorthe E, Gallot D, Madar H, Doret-Dion M, Beucher G, Charlier C, Cazanave C, Delorme P, Garabedian C, Azria E, Tessier V, Senat MV, Kayem G. Preterm premature rupture of the membranes: Guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2019 May;236:1-6. doi: 10.1016/j.ejogrb.2019.02.021. Epub 2019 Mar 2.
PubMed 30870741Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;2014(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.
PubMed 24901312Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
PubMed 35947046Lorthe E, Kayem G; TOCOPROM Study Group and the GROG (Groupe de Recherche en Obstetrique et Gynecologie). Tocolysis in the management of preterm prelabor rupture of membranes at 22-33 weeks of gestation: study protocol for a multicenter, double-blind, randomized controlled trial comparing nifedipine with placebo (TOCOPROM). BMC Pregnancy Childbirth. 2021 Sep 8;21(1):614. doi: 10.1186/s12884-021-04047-2.
PubMed 34496799
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03976063
- Acronym / sponsor ID
- TOCOPROM / P160917
- Conditions
- Preterm Premature Rupture of Membrane
- Keywords
- Preterm premature rupture of membranes, Tocolysis, Nifedipine, Latency, Neonatal outcome, Preterm birth, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 857 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Ministry of Health, France, Groupe de Recherche en Obstétrique et Gynécologie, URC-CIC Paris Descartes Necker Cochin
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 5 Jun 2019 (actual)
- 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 study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
Detailed description
Preterm premature rupture of membranes (PPROM) complicates 3% of pregnancies and accounts for one-third of preterm births. It is a leading cause of neonatal mortality and morbidity and increases the risk of maternal infectious morbidity. In cases of early PPROM (22 to 33 completed weeks' gestation), expectant management is recommended in the absence of labor, chorioamnionitis or fetal distress. Antenatal steroids and antibiotics administration are recommended by international guidelines. However, there is no recommendation regarding tocolysis administration in the setting of PPROM. In theory, reducing uterine contractility should delay delivery and reduce risks of prematurity and neonatal adverse consequences. Likewise, a prolongation of gestation may allow administering a corticosteroids complete course that is associated with a two-fold reduction of morbidity and mortality. However, tocolysis may prolong fetal exposure to inflammation and be associated with higher risk of materno-fetal infection, potentially associated with neonatal death or long-term sequelae, including cerebral palsy.
The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Active comparator | Drug: Nifedipine |
| Placebo | Placebo comparator | Drug: Placebo of Nifedipine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of gestation, as diagnosed by obstetric team
- Singleton gestation
- Fetus alive at the time of randomization (reassuring fetal heart monitoring)
- 18 years of age or older
- French speaking
Key exclusion criteria (17 listed)
- PPROM ≥ 24 hours before diagnosis
- Ongoing tocolytic treatment at the time of PPROM
- Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization
- Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
- Cervical dilation > 5 cm
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 |
|---|---|---|
| NifedipineLoading dose: Oral Nifedipine 20 mg prolonged-release at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg prolonged-release at T3, then 1 pill every 8 hr for 48 hr (i.e. T11, T19, T27, T35 and T43, total=6x20 mg) | Drug | Nifedipine |
| Placebo of NifedipineOral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43 | Drug | Placebo |
Primary outcome
Perinatal morti-morbidity
Time frame: Up to discharge from hospital, with a maximum of 24 weeks after birth.
Composite outcome including fetal death, neonatal death and/or neonatal severe morbidity (mechanical ventilation ≥ 48 hrs, severe bronchopulmonary dysplasia, severe intraventricular hemorrhage, cystic periventricular leucomalacia, neonatal early-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity).
25 secondary outcomes
Prolongation of gestation
Time frame: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Prolongation of gestation
Time frame: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Prolongation of gestation
Time frame: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Prolongation of gestation
Time frame: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Prolongation of gestation
Time frame: Up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Maternal morbidity
Time frame: During the first 10 days postpartum
Maternal morbidity
Time frame: At delivery
Fetal mortality
Time frame: Up to delivery so up to 20 weeks after PPROM (i.e. up to the maximum duration of a normal pregnancy)
Neonatal mortality
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Time frame: From birth to Day 3 after birth.
Neonatal severe morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal severe morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal morbidity
Time frame: At birth.
Neonatal morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal morbidity
Time frame: From birth to discharge from hospital, with a maximum of 24 weeks after birth.
Neonatal morbidity
Time frame: From Day 3 after birth to discharge from hospital, with a maximum of 24 weeks after birth.
Vital status
Time frame: At 22-26 months of corrected age
Frequency of Gross motor impairment among children alive at 2 years of corrected age
Time frame: At 22-26 months of corrected age
Frequency of Neurosensory impairment among children alive at 2 years of corrected age
Time frame: At 22-26 months of corrected age
Frequency of Neurosensory impairment among children alive at 2 years of corrected age
Time frame: At 22-26 months of corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 24578236Mackeen AD, Seibel-Seamon J, Muhammad J, Baxter JK, Berghella V. Tocolytics for preterm premature rupture of membranes. Cochrane Database Syst Rev. 2014 Feb 27;2014(2):CD007062. doi: 10.1002/14651858.CD007062.pub3.
- Background: PubMed 28412086Lorthe E, Goffinet F, Marret S, Vayssiere C, Flamant C, Quere M, Benhammou V, Ancel PY, Kayem G. Tocolysis after preterm premature rupture of membranes and neonatal outcome: a propensity-score analysis. Am J Obstet Gynecol. 2017 Aug;217(2):212.e1-212.e12. doi: 10.1016/j.ajog.2017.04.015. Epub 2017 Apr 13.
- Background: PubMed 23182704Couteau C, Haumonte JB, Bretelle F, Capelle M, D'Ercole C. [Management of preterm and prelabour rupture of membranes in France]. J Gynecol Obstet Biol Reprod (Paris). 2013 Feb;42(1):21-8. doi: 10.1016/j.jgyn.2012.10.008. Epub 2012 Nov 24. French.
- Background: PubMed 30870741Schmitz T, Sentilhes L, Lorthe E, Gallot D, Madar H, Doret-Dion M, Beucher G, Charlier C, Cazanave C, Delorme P, Garabedian C, Azria E, Tessier V, Senat MV, Kayem G. Preterm premature rupture of the membranes: Guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2019 May;236:1-6. doi: 10.1016/j.ejogrb.2019.02.021. Epub 2019 Mar 2.
- Background: PubMed 24901312Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;2014(6):CD002255. doi: 10.1002/14651858.CD002255.pub2.
- Derived from this study: PubMed 35947046Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
- Derived from this study: PubMed 34496799Lorthe E, Kayem G; TOCOPROM Study Group and the GROG (Groupe de Recherche en Obstetrique et Gynecologie). Tocolysis in the management of preterm prelabor rupture of membranes at 22-33 weeks of gestation: study protocol for a multicenter, double-blind, randomized controlled trial comparing nifedipine with placebo (TOCOPROM). BMC Pregnancy Childbirth. 2021 Sep 8;21(1):614. doi: 10.1186/s12884-021-04047-2.
- Individual participant dataSharing planned: Undecided
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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.
Gilles Kayem, MD, PhD principal investigator
INSERM UMR 1153, Obstetrical, Perinatal and PEdiatric Epidemiology (EPOPé) Research Team, Center of Research in Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital
Elsa Lorthe, RM, PhD study director
INSERM UMR 1153, Obstetrical, Perinatal and PEdiatric Epidemiology (EPOPé) Research Team, Center of Research in Epidemiology and Statistics Sorbonne Paris Cité (CRESS), DHU Risks in Pregnancy, Paris Descartes University
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 Nifedipine in people with Preterm Premature Rupture of Membrane, 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 7 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Perinatal morti-morbidity (time frame: Up to discharge from hospital, with a maximum of 24 weeks after birth.). 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 NCT03976063, which also lists 7 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 23 Apr 2026.