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Utility of Tocolytic Therapy for Maintenance Tocolysis in the Management of Threatened Preterm Delivery (UTM/2012)

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ClinicalTrials.gov Identifier: NCT01796522
Recruitment Status : Withdrawn (have been published new studies that it showed the ineffectiveness of the treatments proposed in this study.)
First Posted : February 21, 2013
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Brief Summary:

Hypothesis: Both nifedipine or progesterone are widely used in clinical practice as maintenance tocolytic therapy after an episode of threatened preterm delivery. Nevertheless, there is insufficient evidence to justify its routine use. The present study aims to evaluate the efficacy and safety of these tocolytic drugs for maintenance tocolysis in the management of threatened preterm delivery.

Materials and methods:

Phase III clinical trial, which evaluates the efficacy and safety of nifedipine and progesterone as maintenance tocolytic therapy until the 34th week of pregnancy in randomized women after an episode of threatened preterm delivery.

Pregnant women with singleton pregnancies are going to be evaluated, with intact membranes and cervical length less than or equal to 25 mm, which have received acute tocolysis with atosiban. They will be randomized to receive maintenance tocolysis with nifedipine (60 mg / day orally) or progesterone (200 mg / day vaginally) until week 34 of gestation. Therefore all included patients will receive treatment with proven but not agreed efficacy, to decrease the recurrence of threatened preterm delivery, prolongation of gestation and subsequent better perinatal outcome. During the course of pregnancy, patients will be monitored in outpatient obstetrics, thus checking an adequate compliance. Monitoring will continue until the end with the delivery and collection of newborn data.

The study will be single-blind, since there will be a blind evaluator. The drugs or treatments not allowed before and / or during the clinical trial are those which are indicated in the data sheet for each drug. If the patient takes antihypertensive treatment and continues it during pregnancy, dose adjustment will be done if it is needed.

Data will be collected in the case report data (CRD). The end of the test will be considered when the last recruited patient complete the gestation (delivered vaginally or cesarean), and all data from newborn are collected. If a serious adverse event occurs in a patient, the woman will immediately finish the clinical trial and will be followed until complete resolution of the episode.

Treatment is going to be considered effective if the birth occurs after 37 weeks of pregnancy with satisfactory perinatal outcome. The drugs are going to be considered safe if they do not cause adverse events in pregnant women, or if they are not serious.

Number of Subjects: 50 pregnant women

Diagnosis and main criteria for inclusion and exclusion:

Inclusion Criteria

  • Pregnant women with singleton pregnancies and intact membranes which have passed an episode of threatened preterm delivery (uterine contractions with cervical change) successfully treated with atosiban as acute tocolytic therapy.
  • Cervical length ≤ 25 mm. Exclusion Criteria
  • ≥ 3 cm cervical dilation, multiple pregnancy, maternal medical contraindication to tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to tocolytic treatment (severe preeclampsia, intrauterine infection, placental abruption, fetal abnormality incompatible with life, fetal death) .

Investigational product, dose and mode of administration: After a successful treatment of acute preterm labor with atosiban, is will be compared the safety and efficacy of maintenance tocolytic therapy with nifedipine 60 mg / day orally or progesterone 200 mg / day vaginally.

Therapeutic group: C08CA05 Nifedipine. G03DA04 micronized progesterone.

Route of administration: nifedipine orally. Progesterone vaginally.

Dose: Nifedipine 60 mg / day. Progesterone 200 mg / day.

Duration of treatment: From the resolution of acute episode of threatened preterm labor until 34 weeks of gestation.

Reference treatment, dose and mode of administration: Current evidence questions the utility of maintenance tocolytic therapy. No reference treatment is currently defined.


Condition or disease Intervention/treatment Phase
Preterm Delivery. Drug: progesterone 200 mg / day vaginally Drug: nifedipine (60 mg / day orally) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Utility of Tocolytic Therapy for Maintenance Tocolysis in the Management of Threatened Preterm Delivery
Study Start Date : March 2013
Actual Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nifedipine (60 mg / day orally)
The name of this arm is Nifedipine. These Prolonged release tablets(Oros) presents a release system for 24h, acting as an osmotic pump releasing the nifedipine through an orifice in the tablet produced by laser technology.The Nifedipine tablet 60mg administered once daily to week 34 of gestation.
Drug: nifedipine (60 mg / day orally)
Active Comparator: Progesterone 200 mg / day vaginally
The name of this arm is Progesterone. Soft gelatin capsule vaginal use, used in clinical practice as maintenance tocolytic therapy after episode of threatened preterm labor. The 200mg capsule administered once daily to week 34 of gestation. The patients assigned to this arm will begin treatment while the patient assigned to the arm of nifedipine.
Drug: progesterone 200 mg / day vaginally



Primary Outcome Measures :
  1. The present study aims to evaluate the efficacy of these tocolytic drugs for maintenance tocolysis in the management of threatened preterm delivery. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The present study aims to evaluate the safety of nifedipine and progesterone as tocolytic drugs for maintenance tocolysis in the management of threatened preterm delivery. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with singleton pregnancies and intact membranes which have passed an episode of threatened preterm delivery (uterine contractions with cervical change) successfully treated with atosiban as acute tocolytic therapy.
  • Cervical length ≤ 25 mm.

Exclusion Criteria:

  • ≥ 3 cm cervical dilation, multiple pregnancy, maternal medical contraindication to tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to tocolytic treatment (severe preeclampsia, intrauterine infection, placental abruption, fetal abnormality incompatible with life, fetal death)

Information from the National Library of Medicine

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): NCT01796522


Locations
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Spain
Hospital Universitari y Politécnic La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe

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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT01796522     History of Changes
Other Study ID Numbers: UTM/2012
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications
Premature Birth
Obstetric Labor, Premature
Nifedipine
Tocolytic Agents
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Reproductive Control Agents