Placenta PreviaPhase 2NCT00620724
Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa
A Phase 2 study testing Nifedipine in people with Placenta Previa, run by University Hospital, Rouen at 1 site in France.
Trial summary
The objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Nifedipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Sep 2012
- 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
- Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasonography
- Placenta previa may be symptomatic with at least one episode of bleeding
- Estimated gestational age within 24 to 34 weeks
- Maternal age > 18 years
- Informed consent after received an explanation of the study and an information sheet
- Social affiliation
Who cannot join
- Premature rupture of membranes
- Severe bleeding requiring an immediate termination of pregnancy
- Abnormal fetal heart rates requiring an immediate termination of pregnancy
- Intrauterine fetal death
- Pre-eclampsia, chorioamnionitis, liver disease, severe chronic renal disease, heart disease
- Abruptio placentae
- Nifedipine sensibility
- Drugs interaction with nifedipine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial
The objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. All patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation.
The primary outcome for the trial is the length of pregnancy in days after the enrollment. A sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.
- Conditions
- Placenta Previa
- Being tested
- Placebo, Nifedipine
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo three times daily
NifedipineDrug
20 mg of slow-release Nifedipine three times daily
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo three times daily Receives: Drug: Placebo |
| B | Experimental | 20 mg of slow-release Nifedipine three times daily Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of pregnancy
Measured: From allocation to the delivery
Secondary outcomes (1)
Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620724
- Sponsor's protocol ID
- 2005/065/HP
- Status last verified
- Jul 2014
- First submitted
- 28 Jan 2008
- Last updated
- 10 Jul 2014
- Results posted
- No
Publications
Verspyck E, Thill C, Ego A, Machevin E, Brasseur-Daudruy M, Ickowicz V, Blondel C, Degre S, Lefebure A, Braund S, Benichou J. Screening for small for gestational age infants in early vs late third-trimester ultrasonography: a randomized trial. Am J Obstet Gynecol MFM. 2023 Nov;5(11):101162. doi: 10.1016/j.ajogmf.2023.101162. Epub 2023 Sep 15.
PubMed 37717697Wilson 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 35947046Verspyck E, de Vienne C, Muszynski C, Bubenheim M, Chanavaz-Lacheray I, Dreyfus M, Deruelle P, Benichou J. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial. PLoS One. 2017 Mar 23;12(3):e0173717. doi: 10.1371/journal.pone.0173717. eCollection 2017.
PubMed 28333939
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00620724
- Acronym / sponsor ID
- 2005/065/HP
- Conditions
- Placenta Previa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Feb 2008 (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 objective of our study is to determine the clinical utility related to the maintenance oral nifedipine therapy in patients with symptomatic placenta previa. This study is a prospective, randomized controlled trial with the inclusion, after 24 weeks gestation, of hospitalized patients with symptomatic placenta praevia. All patients may initially receive oral nifedipine therapy with steroid prophylaxis for 48 hours. After then, patients are randomly assigned to receive either oral nifedipine (20 mg every 8 hours) or placebo (one every 8 hours) until 37 weeks of gestation.
The primary outcome for the trial is the length of pregnancy in days after the enrollment. A sample size calculation is designed to detect at least a 14 -day difference in time gained in patients with maintenance oral nifedipine therapy. A sample size of about 52 patients per group would have a 80 % chance of detecting this difference at the 5 % level of significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PlaceboPlacebo three times daily |
| B | Experimental | Drug: Nifedipine20 mg of slow-release Nifedipine three times daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasonography
- Placenta previa may be symptomatic with at least one episode of bleeding
- Estimated gestational age within 24 to 34 weeks
- Maternal age > 18 years
- Informed consent after received an explanation of the study and an information sheet
Key exclusion criteria (8 listed)
- Premature rupture of membranes
- Severe bleeding requiring an immediate termination of pregnancy
- Abnormal fetal heart rates requiring an immediate termination of pregnancy
- Intrauterine fetal death
- Pre-eclampsia, chorioamnionitis, liver disease, severe chronic renal disease, heart disease
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 |
|---|---|---|
| PlaceboPlacebo three times daily | Drug | A |
| Nifedipine20 mg of slow-release Nifedipine three times daily | Drug | B |
Primary outcome
Prolongation of pregnancy
Time frame: From allocation to the delivery
1 secondary outcome
Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required
Time frame: At the end of the study
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 10 Jul 2014.
- Derived from this study: PubMed 37717697Verspyck E, Thill C, Ego A, Machevin E, Brasseur-Daudruy M, Ickowicz V, Blondel C, Degre S, Lefebure A, Braund S, Benichou J. Screening for small for gestational age infants in early vs late third-trimester ultrasonography: a randomized trial. Am J Obstet Gynecol MFM. 2023 Nov;5(11):101162. doi: 10.1016/j.ajogmf.2023.101162. Epub 2023 Sep 15.
- 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 28333939Verspyck E, de Vienne C, Muszynski C, Bubenheim M, Chanavaz-Lacheray I, Dreyfus M, Deruelle P, Benichou J. Maintenance nifedipine therapy for preterm symptomatic placenta previa: A randomized, multicenter, double-blind, placebo-controlled trial. PLoS One. 2017 Mar 23;12(3):e0173717. doi: 10.1371/journal.pone.0173717. eCollection 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nifedipine in people with Placenta Previa, run by University Hospital, Rouen 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 6 inclusion and 8 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 10 Jul 2014. 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 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?
Prolongation of pregnancy (time frame: From allocation to the 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 NCT00620724, 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 10 Jul 2014.