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Tocolytic Therapy for Preterm Labor in Multiple Gestation

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ClinicalTrials.gov Identifier: NCT02725736
Recruitment Status : Unknown
Verified March 2016 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 1, 2016
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of calcium channel blockers (Nifedipine) among women with multiple gestation who present with threatened preterm labor.

Condition or disease Intervention/treatment Phase
Labor Preterm Multiple Drug: Atosiban Drug: Nifedipine Phase 3

Detailed Description:

Preterm birth remains the principal cause of early neonatal death. Infants born preterm (before 37 weeks' gestation) often suffer significant immediate morbidity and need lengthy stays in neonatal intensive care units. Moreover, there is a significant risk of long-term neurological morbidity in a proportion of the survivors. Patients with a multiple gestation are at significant risk for preterm labor and delivery as approximately 60% of all those pregnancies will be delivered preterm.

A number of oxytocin receptor antagonists have been developed, and of these, three, atosiban, barusiban and retosiban have been investigated in humans as tocolytic agents. To date, only atosiban is in use outside of clinical trials. Atosiban is an oxytocin receptor antagonist which was specifically developed for the treatment of preterm labor. Early reports of the use of Atosiban for tocolysis showed promise both in vitro and in animal studies, and preliminary studies in pregnant and non-pregnant humans suggested a very low incidence of maternal side effects .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tocolytic Therapy for Preterm Labor in Multiple Gestation
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atosiban
Women with twin pregnancy with preterm labor between 24 weeks 0 days and 32 weeks 6 days of gestation will be included and randomly assigned to the Atosiban group.
Drug: Atosiban

After random allocation to a treatment group, women will receive Atosiban as follows:

Atosiban was given as a single loading intravenous dose, 6.75 mg in 0.9% sodium chloride solution, followed by an intravenous infusion of 300 micrograms/min in 0.9% sodium chloride solution for the first 3 hours and then 100 micrograms/min for another 45 hours. The choice of the dose regimen for Atosiban was consistent with the recommendations of the product labeling.


Experimental: Nifedipine
Women with twin pregnancy with preterm labor between 24 weeks 0 days and 32 weeks 6 days of gestation will be included and randomly assigned to the Nifedipine group.
Drug: Nifedipine

After random allocation to a treatment group, women will receive Nifedipine as follows:

Nifedipine was given as a loading dose of 20 mg orally followed by another two doses of 20 mg, 20-30 minutes apart as needed. Maintenance was started after 6 hours with 20-40 mg four times a day for a total of 48 hours.





Primary Outcome Measures :
  1. Duration of labor [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Infant morbidity [ Time Frame: 28 days ]
    Defined as the number of infant morbidity up to 28 days from birth.

  2. Chronic lung disease [ Time Frame: 28 days ]
    Defined as the number of participants with need for supplemental oxygen at 28 days of life



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Twin pregnancy
  2. Gestational age between 24+0 and 32+6 weeks
  3. Intact amniotic membranes
  4. Threatened preterm labor
  5. Age 18-50.

Exclusion Criteria:

  1. Rupture of membranes
  2. Vaginal bleeding resulting from placenta previa or placental abruption
  3. Fever above 38°C
  4. Severe preeclampsia
  5. Maternal cardiovascular or liver diseases
  6. Systolic blood pressure less than 90 mm Hg
  7. Known uterine malformation
  8. Intrauterine growth restriction below the fifth percentile
  9. Non-reassuring fetal status
  10. Antepartum diagnosis of major fetal malformations
  11. Fetal death
  12. Previous tocolytic therapy or Betamethasone treatment

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): NCT02725736


Contacts
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Contact: Yariv Yogev, professor 052-7360616 yarivy@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Yariv Yogev, professor Tel Aviv Medical Center

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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02725736     History of Changes
Other Study ID Numbers: 755-15-TLV
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Atosiban
Tocolytic Agents
Vasotocin
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Reproductive Control Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Oxytocics
Vasoconstrictor Agents