Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa
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ClinicalTrials.gov Identifier: NCT00620724 |
Recruitment Status :
Completed
First Posted : February 21, 2008
Last Update Posted : July 10, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Placenta Previa | Drug: Placebo Drug: Nifedipine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 109 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: A
Placebo three times daily
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Drug: Placebo
Placebo three times daily |
Experimental: B
20 mg of slow-release Nifedipine three times daily
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Drug: Nifedipine
20 mg of slow-release Nifedipine three times daily |
- Prolongation of pregnancy [ Time Frame: From allocation to the delivery ]
- Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required [ Time Frame: At the end of the study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620724
France | |
University Hospital Rouen | |
Rouen, France, 76031 |
Responsible Party: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00620724 |
Other Study ID Numbers: |
2005/065/HP |
First Posted: | February 21, 2008 Key Record Dates |
Last Update Posted: | July 10, 2014 |
Last Verified: | July 2014 |
Nifedipine Placenta Previa Obstetric Labor Complications Pregnancy Complications Placenta Diseases Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Tocolytic Agents Reproductive Control Agents |