Tocolytic Therapy for Preterm Labor in Multiple Gestation

NCT02725736 | Unknown Phase 3

• 1 other identifier: 755-15-TLV
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Labor Preterm Multiple

Outcome Measures

Primary Outcomes (1)

• Duration of labor

  48 hours

Secondary Outcomes (2)

• Infant morbidity

  28 days

• Chronic lung disease

  28 days

Study Arms (2)

Atosiban

EXPERIMENTAL

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

Nifedipine

EXPERIMENTAL

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

Interventions

Atosiban DRUG

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.

Atosiban

Nifedipine DRUG

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.

Nifedipine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Twin pregnancy
• Gestational age between 24+0 and 32+6 weeks
• Intact amniotic membranes
• Threatened preterm labor
• Age 18-50.

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (1)

• Wilson 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.

  PMID: 35947046 DERIVED

MeSH Terms

Interventions

atosiban; Nifedipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yariv Yogev, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yariv Yogev, professor

CONTACT

052-7360616; yarivy@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 1, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 1, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share