Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (have been published new studies that it showed the ineffectiveness of the treatments proposed in this study.)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

Tracking Information
First Submitted Date  ICMJE February 14, 2013
First Posted Date  ICMJE February 21, 2013
Last Update Posted Date July 22, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01796522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Utility of Tocolytic Therapy for Maintenance Tocolysis in the Management of Threatened Preterm Delivery
Official Title  ICMJE Utility of Tocolytic Therapy for Maintenance Tocolysis in the Management of Threatened Preterm Delivery
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Preterm Delivery.
Intervention  ICMJE
  • Drug: progesterone 200 mg / day vaginally
  • Drug: nifedipine (60 mg / day orally)
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: progesterone 200 mg / day vaginally
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 21, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2013)
50
Estimated Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01796522
Other Study ID Numbers  ICMJE UTM/2012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigacion Sanitaria La Fe
Study Sponsor  ICMJE Instituto de Investigacion Sanitaria La Fe
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Instituto de Investigacion Sanitaria La Fe
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP