Children Born to Mothers Enrolled in the TOCOPROM TrialTOCOKIDSNCT07146451
6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
An observational study of Children Born to Mothers Enrolled in the TOCOPROM Trial, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the neurodevelopment at age 6 of children born to women with preterm prelabor rupture of membranes at 22 to 33 weeks of gestation, after antenatal exposure to nifedipine vs placebo. Read more about this study
- Who is it for?
- Ages 6 years to 78 months
- Conditions the study is for
- Children Born to Mothers Enrolled in the TOCOPROM Trial
- What is being tested?
- Self-administered parental questionnaire and A short psychological assessment performed online
- Type of treatment
- Pill or oral medicine
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2025to Sep 2034
- Phase
- Observational
- 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 6 years to 78 months
- All sexes
- No healthy volunteers
- Child
Study population: Children born to women enrolled in the TOCOPROM trial reaching the age of 6 years
Who may be able to join
- All children born to mothers enrolled in the TOCOPROM trial who consented to participate in the 2-year follow-up and who agreed to be contacted for the 6-year follow-up
- Alive at 6 years
- Internet access, including access to a good-quality video-conference system (only for the psychological evaluation)
- Non opposition of the holders of the exercise of parental authority
Who cannot join
- Major malformations and/or chromosomal aberrations evidenced after birth
- Impossibility to contact the family
- Opposition to participate in the follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Trousseau University Hospital
Paris, France, 75012
Gilles KAYEM, MD, PHD, 01 44 73 51 18 ext. +33, gilles.kayem@aphp.fr
About this study
Official title: 6-year Follow-up of Children Born to Mothers Exposed to Nifedipine vs Placebo After Preterm Prelabor Rupture of Membranes at 22 to 33 Weeks of Gestation
The purpose of this study is to evaluate the neurodevelopment at age 6 of children born to women with preterm prelabor rupture of membranes at 22 to 33 weeks of gestation, after antenatal exposure to nifedipine vs placebo.
Read the detailed description
Preterm prelabor 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 the 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 investigators implemented the TOCOPROM randomized clinical trial to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22-33 weeks. However, both short- and long-term outcomes should be taken into account to define the optimal treatment strategy. There are currently no data allowing to evaluate the impact of a short course of nifedipine versus placebo on neurodevelopmental outcomes in school-aged children born after PPROM. Therefore, following-up children born to mothers enrolled in the TOCOPROM trial, through a new study, the TOCOKIDS cohort, is a unique and timely opportunity to advance scientific knowledge and adapt clinical practices in France and worldwide.
The assessment at 6 years of age will consist in:
- A self-administered parental questionnaire, completed online or on paper
- Data collected from the health book, in particular the 6-year consultation
- A short psychological assessment (45 minutes), performed remotely by a psychologist through video conference.
- Being tested
- Self-administered parental questionnaire, A short psychological assessment performed online
- Keywords
- Prematurity, Nifedipine, Psychological assessment, Neurodevelopment, School age, Preterm prelabor rupture of membranes
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered parental questionnaireOther
A self-administered parental questionnaire, completed online or on paper, to assess different dimension of neurodevelopment
A short psychological assessment performed onlineOther
NEMI-3: an intelligence test administered by a psychologist measuring a fluid and crystallised intelligence. The test consists of 117 spoken and visual questions, for a total administration time of 45 min. Results are expressed in the form of standard indices (mean 100, standard deviation 15) that facilitate comparisons with the results obtained on other intelligence scales.
Results will be classified as normal, mild delay (between 1 and <2 standard deviation [SD] below the mean) or severe delay (≥2 SD).
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Exposure during pregnancy to Oral Nifedipine 20 mg LP (between 22 to 33 weeks of gestation): Loading dose at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose:
Oral Nifedipine 20 mg LP at T3, then 1 pill every 8 hours for 48 hours (i.e. T11, T19, T27, T35 and T43, total=6x20 mg) Receives: Other: Self-administered parental questionnaire | |
| Placebo | Exposure during pregnancy to oral placebo of nifedipine (between 22 to 33 weeks of gestation) at T0, T0.5, T3, T11, T19, T27, T35 and T43 Receives: Other: A short psychological assessment performed online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral palsy at 6 years of age.
Cerebral palsy assessed using the Gross Motor Function Classification System (GMFCS), a five-level classification based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.
Severe/moderate cerebral palsy (GMFCS≥2). Mild cerebral palsy (GMFCS-1).
Measured: Up to 6 months after inclusion.
Developmental Coordination Disorder at 6 years of age.
Measured using the Developmental Coordination Disorder Questionnaire - European French (DCDQ-FE), a brief parent questionnaire (15 items) designed to screen for gross and fine motor skills and coordination disorders in children, aged 5 to 15 years.
Total score=15-56: indication of a risk of DCD or suspected of a risk of DCD. Total score=57-75: probably no DCD.
Measured: Up to 6 months after inclusion.
Language at 6 years of age
Language assessed using the verbal communication subscale (4 items) of the 5-15R scale, covering comprehension, expressive language skills and verbal communication, with an extra question on the impact of language and communication difficulties on daily activities.
Mean (SD). Reference to cut-off scores in relation to the 90 and 98 percentiles (%).
Measured: Up to 6 months after inclusion.
Behavior at 6 years of age.
Behavior assessed using the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire (25 items), designed to screen for symptoms of hyperactivity inattention, emotional, conduct, and peer problems among 2-17 year olds.
Mean (SD). Abnormal: >90th percentile. Mildly abnormal: 80-90 percentile.
Measured: Up to 6 months after inclusion.
Executive functions at 6 years of age.
Executive functions measured using the Childhood Executive Functioning Inventory (CHEXI), a rating instrument (24 items) for parents that was developed for measuring executive functioning in children age 4-12. It includes four different subscales tapping working memory, planning, regulation and inhibition, combined into two global scales: working memory (working memory and planning subscales) and inhibition (inhibition and regulation subscales).
Normative data are not yet available. Abnormality will be defined considering a cut-off or deviation compared to the mean score, depending on the literature.
Measured: Up to 6 months after inclusion.
Secondary outcomes (23)
Vital status at 6 years of age.
Whether the child is alive or not at years of age.
Measured: Up to 6 months after inclusion.
Neurodevelopmental impairment.
Moderate-to-severe impairment (severe/moderate cerebral palsy, and/or abnormal SDQ score, and/or NEMI-3 ≥2 SD below the mean, and/or blindness, and/or deafness), mild impairment (mildly abnormal scores or mild impairment) vs no neurodevelopmental impairment.
Measured: Up to 6 months after inclusion.
Survival without any neurodevelopmental impairment at 6 years of age.
Survival without any neurodevelopmental impairment (as defined in the primary endpoint, and then including also cognitive impairment).
Measured: Up to 6 months after inclusion.
Survival without moderate-to-severe neurodevelopmental impairment at 6 years of age.
Survival without moderate-to-severe neurodevelopmental impairment (i.e. severe/moderate cerebral palsy, and/or abnormal SDQ score, and/or NEMI-3 ≥2 SD below the mean, and/or blindness, and/or deafness).
Measured: Up to 6 months after inclusion.
Growth at 6 years of age.
Height compulsory examination in the sixth year, reported in the health book.
Measured: Up to 6 months after inclusion.
Growth at 6 years of age
Weight. Compulsory examination in the sixth year, reported in the health book
Measured: Up to 6 months after inclusion
Health at 6 years of age.
Arterial pressure. Compulsory examination in the sixth year, reported in the health book.
Measured: Up to 6 months after inclusion.
Health at 6 years of age
chronic diseases, compulsory examination in the sixth year, reported in the health book
Measured: Up to 6 months after inclusion
Health at 6 years of age
oral health. Compulsory examination in the sixth year, reported in the health book
Measured: Up to 6 months after inclusion
Vision at 6 years of age.
Visual acuity, any vision problem mentioned. Compulsory examination in the sixth year, reported in the health book.
Measured: Up to 6 months after inclusion.
Hearing at 6 years of age.
Hearing test. Compulsory examination in the sixth year, reported in the health book.
Measured: Up to 6 months after inclusion.
Development at 6 years of age.
Data reported in the health book during the compulsory examination in the sixth year.
Measured: Up to 6 months after inclusion.
Language at 6 years of age.
Language test. Compulsory examination in the sixth year, reported in the health book.
Measured: Up to 6 months after inclusion.
Behaviour at 6 years of age.
Data reported in the health book during the compulsory examination in the sixth year.
Measured: Up to 6 months after inclusion.
Cognition at 6 years of age.
NEMI-3: an intelligence test administered by a psychologist measuring a fluid and crystallised intelligence. The test consists of 117 spoken and visual questions, for a total administration time of 45 min. Results are expressed in the form of standard indices (mean 100, standard deviation 15) that facilitate comparisons with the results obtained on other intelligence scales.
Results will be classified as normal, mild delay (between 1 and <2 standard deviation [SD] below the mean) or severe delay (≥2 SD).
Measured: Up to 6 months after inclusion.
Feasibility of performing an online psychological evaluation.
Acceptability E-Scale (adapted - 3 items), participation and completion rates, technical difficulties.
Measured: Up to 6 months after inclusion.
Parent-reported health and development.
Self-reported. Perceived health and development of the child, parental concerns about health and development, and professional diagnoses of health conditions (e.g., asthma, respiratory problems, etc.).
Measured: Up to 6 months after inclusion.
Parent-reported Health-Related Quality of Life.
PedsQL Short Form - 15 items. All items will be added up and linearly transformed on a scale between 0 and 100, a higher score indicating a better HRQoL. Physical and psychosocial functioning will be further assessed using the corresponding subscales. Poor HRQoL, physical or psychosocial functioning will be defined using thresholds compatible with a severe health condition.
Measured: Up to 6 months after inclusion.
Parent-reported school difficulties
Ad-hoc questions
Measured: Up to 6 months after inclusion
Maternal self-perceived health
Minimum European Health Module - 1 item
Measured: Up to 6 months after inclusion
Maternal mental health
PHQ-4 (anxiety and depression) - 4 items
Measured: Up to 6 months after inclusion
Maternal well-being
WHO-5 Well-Being Index - 5 items
Measured: Up to 6 months after inclusion
Maternal quality of life
WHOQOL bref FR - 1 item
Measured: Up to 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start28 Oct 2025
- Primary completionSep 2033 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Children Born to Mothers Enrolled in the TOCOPROM TrialStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
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
- Gilles KAYEM, MD,PhD, Principal investigator, Université Paris Cité and Université Sorbonne Paris Nord, Paris, France. DHU Risks in Pregnancy, Paris Descartes University, Trousseau University HospitalElsa LORTHE, RM,PhD, Study director, Université Paris Cité and Université Sorbonne Paris Nord, Paris, France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146451
- Sponsor's protocol ID
- APHP230846
- Acronym
- TOCOKIDS
- Status last verified
- Feb 2026
- First submitted
- 16 Jul 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Houtzager BA, Hogendoorn SM, Papatsonis DN, Samsom JF, van Geijn HP, Bleker OP, van Wassenaer AG. Long-term follow up of children exposed in utero to nifedipine or ritodrine for the management of preterm labour. BJOG. 2006 Mar;113(3):324-31. doi: 10.1111/j.1471-0528.2006.00851.x.
PubMed 16487205Van De Water M, Kessel ET, De Kleine MJ, Oei SG. Tocolytic effectiveness of nifedipine versus ritodrine and follow-up of newborns: a randomised controlled trial. Acta Obstet Gynecol Scand. 2008;87(3):340-5. doi: 10.1080/00016340801913189.
PubMed 18307075van Vliet E, Seinen L, Roos C, Schuit E, Scheepers H, Bloemenkamp K, Duvekot JJ, van Eyck J, Kok JH, Lotgering FK, van Baar A, van Wassenaer-Leemhuis AG, Franssen MT, Porath MM, van der Post J, Franx A, Mol B, Oudijk MA. Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial. BJOG. 2016 Jun;123(7):1107-14. doi: 10.1111/1471-0528.13586. Epub 2015 Aug 27.
PubMed 26330379van Winden T, Klumper J, Kleinrouweler CE, Tichelaar MA, Naaktgeboren CA, Nijman TA, van Baar AL, van Wassenaer-Leemhuis AG, Roseboom TJ, Van't Hooft J, Roos C, Mol BW, Pajkrt E, Oudijk MA. Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial. BJOG. 2020 Aug;127(9):1129-1137. doi: 10.1111/1471-0528.16186. Epub 2020 Mar 29.
PubMed 32124520Wilson 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6-year Follow-up of Children Born to Mothers Exposed to Nifedipine vs Placebo After Preterm Prelabor Rupture of Membranes at 22 to 33 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT07146451
- Acronym / sponsor ID
- TOCOKIDS / APHP230846
- Keywords
- Prematurity, Nifedipine, Psychological assessment, Neurodevelopment, School age, Preterm prelabor rupture of membranes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Sep 2033 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 28 Aug 2025 (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 evaluate the neurodevelopment at age 6 of children born to women with preterm prelabor rupture of membranes at 22 to 33 weeks of gestation, after antenatal exposure to nifedipine vs placebo.
Detailed description
Preterm prelabor 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 the 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 investigators implemented the TOCOPROM randomized clinical trial to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22-33 weeks. However, both short- and long-term outcomes should be taken into account to define the optimal treatment strategy. There are currently no data allowing to evaluate the impact of a short course of nifedipine versus placebo on neurodevelopmental outcomes in school-aged children born after PPROM. Therefore, following-up children born to mothers enrolled in the TOCOPROM trial, through a new study, the TOCOKIDS cohort, is a unique and timely opportunity to advance scientific knowledge and adapt clinical practices in France and worldwide.
The assessment at 6 years of age will consist in:
- A self-administered parental questionnaire, completed online or on paper
- Data collected from the health book, in particular the 6-year consultation
- A short psychological assessment (45 minutes), performed remotely by a psychologist through video conference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | – | Other: Self-administered parental questionnaireExposure during pregnancy to Oral Nifedipine 20 mg LP (between 22 to 33 weeks of gestation): Loading dose at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg LP at T3, then 1 pill every 8 hours for 48 hours (i.e. T11, T19, T27, T35 and T43, total=6x20 mg) |
| Placebo | – | Other: A short psychological assessment performed onlineExposure during pregnancy to oral placebo of nifedipine (between 22 to 33 weeks of gestation) at T0, T0.5, T3, T11, T19, T27, T35 and T43 |
Who may qualify
- Ages
- 6 years to 78 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children born to women enrolled in the TOCOPROM trial reaching the age of 6 years
Key inclusion criteria (4 listed)
- All children born to mothers enrolled in the TOCOPROM trial who consented to participate in the 2-year follow-up and who agreed to be contacted for the 6-year follow-up
- Alive at 6 years
- Internet access, including access to a good-quality video-conference system (only for the psychological evaluation)
- Non opposition of the holders of the exercise of parental authority
Key exclusion criteria (3 listed)
- Major malformations and/or chromosomal aberrations evidenced after birth
- Impossibility to contact the family
- Opposition to participate in the follow-up
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 |
|---|---|---|
| Self-administered parental questionnaireA self-administered parental questionnaire, completed online or on paper, to assess different dimension of neurodevelopment | Other | Nifedipine |
| A short psychological assessment performed onlineNEMI-3: an intelligence test administered by a psychologist measuring a fluid and crystallised intelligence. The test consists of 117 spoken and visual questions, for a total administration time of 45 min. Results are expressed in the form of standard indices (mean 100, standard deviation 15) that facilitate comparisons with the results obtained on other intelligence scales. Results will be classified as normal, mild delay (between 1 and <2 standard deviation [SD] below the mean) or severe delay (≥2 SD). | Other | Placebo |
Primary outcome
Cerebral palsy at 6 years of age.
Time frame: Up to 6 months after inclusion.
Cerebral palsy assessed using the Gross Motor Function Classification System (GMFCS), a five-level classification based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility. Severe/moderate cerebral palsy (GMFCS≥2). Mild cerebral palsy (GMFCS-1).
Developmental Coordination Disorder at 6 years of age.
Time frame: Up to 6 months after inclusion.
Measured using the Developmental Coordination Disorder Questionnaire - European French (DCDQ-FE), a brief parent questionnaire (15 items) designed to screen for gross and fine motor skills and coordination disorders in children, aged 5 to 15 years. Total score=15-56: indication of a risk of DCD or suspected of a risk of DCD. Total score=57-75: probably no DCD.
Language at 6 years of age
Time frame: Up to 6 months after inclusion.
Language assessed using the verbal communication subscale (4 items) of the 5-15R scale, covering comprehension, expressive language skills and verbal communication, with an extra question on the impact of language and communication difficulties on daily activities. Mean (SD). Reference to cut-off scores in relation to the 90 and 98 percentiles (%).
Behavior at 6 years of age.
Time frame: Up to 6 months after inclusion.
Behavior assessed using the Strengths and Difficulties Questionnaire (SDQ), a brief behavioral screening questionnaire (25 items), designed to screen for symptoms of hyperactivity inattention, emotional, conduct, and peer problems among 2-17 year olds. Mean (SD). Abnormal: >90th percentile. Mildly abnormal: 80-90 percentile.
Executive functions at 6 years of age.
Time frame: Up to 6 months after inclusion.
Executive functions measured using the Childhood Executive Functioning Inventory (CHEXI), a rating instrument (24 items) for parents that was developed for measuring executive functioning in children age 4-12. It includes four different subscales tapping working memory, planning, regulation and inhibition, combined into two global scales: working memory (working memory and planning subscales) and inhibition (inhibition and regulation subscales). Normative data are not yet available. Abnormality will be defined considering a cut-off or deviation compared to the mean score, depending on the literature.
23 secondary outcomes
Vital status at 6 years of age.
Time frame: Up to 6 months after inclusion.
Neurodevelopmental impairment.
Time frame: Up to 6 months after inclusion.
Survival without any neurodevelopmental impairment at 6 years of age.
Time frame: Up to 6 months after inclusion.
Survival without moderate-to-severe neurodevelopmental impairment at 6 years of age.
Time frame: Up to 6 months after inclusion.
Growth at 6 years of age.
Time frame: Up to 6 months after inclusion.
Growth at 6 years of age
Time frame: Up to 6 months after inclusion
Health at 6 years of age.
Time frame: Up to 6 months after inclusion.
Health at 6 years of age
Time frame: Up to 6 months after inclusion
Health at 6 years of age
Time frame: Up to 6 months after inclusion
Vision at 6 years of age.
Time frame: Up to 6 months after inclusion.
Hearing at 6 years of age.
Time frame: Up to 6 months after inclusion.
Development at 6 years of age.
Time frame: Up to 6 months after inclusion.
Language at 6 years of age.
Time frame: Up to 6 months after inclusion.
Behaviour at 6 years of age.
Time frame: Up to 6 months after inclusion.
Cognition at 6 years of age.
Time frame: Up to 6 months after inclusion.
Feasibility of performing an online psychological evaluation.
Time frame: Up to 6 months after inclusion.
Parent-reported health and development.
Time frame: Up to 6 months after inclusion.
Parent-reported Health-Related Quality of Life.
Time frame: Up to 6 months after inclusion.
Parent-reported school difficulties
Time frame: Up to 6 months after inclusion
Maternal self-perceived health
Time frame: Up to 6 months after inclusion
Maternal mental health
Time frame: Up to 6 months after inclusion
Maternal well-being
Time frame: Up to 6 months after inclusion
Maternal quality of life
Time frame: Up to 6 months after inclusion
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 13 Feb 2026.
- Background: PubMed 16487205Houtzager BA, Hogendoorn SM, Papatsonis DN, Samsom JF, van Geijn HP, Bleker OP, van Wassenaer AG. Long-term follow up of children exposed in utero to nifedipine or ritodrine for the management of preterm labour. BJOG. 2006 Mar;113(3):324-31. doi: 10.1111/j.1471-0528.2006.00851.x.
- Background: PubMed 18307075Van De Water M, Kessel ET, De Kleine MJ, Oei SG. Tocolytic effectiveness of nifedipine versus ritodrine and follow-up of newborns: a randomised controlled trial. Acta Obstet Gynecol Scand. 2008;87(3):340-5. doi: 10.1080/00016340801913189.
- Background: PubMed 26330379van Vliet E, Seinen L, Roos C, Schuit E, Scheepers H, Bloemenkamp K, Duvekot JJ, van Eyck J, Kok JH, Lotgering FK, van Baar A, van Wassenaer-Leemhuis AG, Franssen MT, Porath MM, van der Post J, Franx A, Mol B, Oudijk MA. Maintenance tocolysis with nifedipine in threatened preterm labour: 2-year follow up of the offspring in the APOSTEL II trial. BJOG. 2016 Jun;123(7):1107-14. doi: 10.1111/1471-0528.13586. Epub 2015 Aug 27.
- Background: PubMed 32124520van Winden T, Klumper J, Kleinrouweler CE, Tichelaar MA, Naaktgeboren CA, Nijman TA, van Baar AL, van Wassenaer-Leemhuis AG, Roseboom TJ, Van't Hooft J, Roos C, Mol BW, Pajkrt E, Oudijk MA. Effects of tocolysis with nifedipine or atosiban on child outcome: follow-up of the APOSTEL III trial. BJOG. 2020 Aug;127(9):1129-1137. doi: 10.1111/1471-0528.16186. Epub 2020 Mar 29.
- Background: 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.
- Background: 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: No
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.
Gilles KAYEM, MD,PhD principal investigator
Université Paris Cité and Université Sorbonne Paris Nord, Paris, France. DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital
Elsa LORTHE, RM,PhD study director
Université Paris Cité and Université Sorbonne Paris Nord, Paris, France.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Born to Mothers Enrolled in the TOCOPROM Trial, 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Gilles KAYEM, MD,PhD (01 44 73 51 18 ext. +33, gilles.kayem@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral palsy at 6 years of age. (time frame: Up to 6 months after inclusion.). The study lists 5 primary outcomes in all. 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 NCT07146451, which also lists 6 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 13 Feb 2026.