Single Versus Combination Therapy in Acute Tocolysis

NCT01429545 | Completed Phase 2 DMC

• 1 other identifier: 06/95
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the tocolytic efficacy, effectiveness and safety of Atosiban in comparison with the combination of Atosiban and Nifedipine together.

Conditions

Preterm Labour

Keywords

Tocolysis; atosiban; nifedipine; combination

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Safety was assessed by maternal, fetal and neonatal adverse events. Particular emphasis was placed on serious adverse cardiovascular events, including cardiac arrest, respiratory arrest, admission to intensive care unit and death were assessed as serious maternal outcomes and perinatal complications were recorded by neonatal morbidity and mortality until discharge from the hospital

  Participants will be followed for the duration of pregnancy, an expected average of 10 weeks

• Number of women undelivered 48 hrs and seven days of initiation of therapy

  Tocolytic efficacy was assessed in terms of the proportion of women undelivered 48 hrs and seven days of initiation of therapy without the need for rescue tocolysis.

  Participants who are not delivered within seven days of initiation of therapy

• Number of Babies with Adverse Events as a Measure of Safety and Tolerability

  Safety was assessed by maternal, fetal and neonatal adverse events. Perinatal complications were recorded by neonatal morbidity and mortality until discharge from the hospital

  participants will be followed for the duration of hospital stay, an expected average of 7 weeks

Secondary Outcomes (2)

• Prolongation of pregnancy

  Assessed till the date of delivery, an expected average of 10 weeks

• Neonatal intensive care unit (NICU) admission

  Till the time of discharge, an expected avearge of 7 weeks

Study Arms (2)

Group 1 - Atosiban

ACTIVE COMPARATOR

Patients on single agent atosiban alone

Drug: Atosiban

Group 2

EXPERIMENTAL

Patients on combination of atosiban and nifedipine

Drug: Atosiban and nifedipine

Interventions

Atosiban DRUG

Atosiban was given as a bolus (6.7 mg. IV) over 1 min then an infusion of 18 mg/hr for 3 hrs followed by 6 mg/hr for 48 hrs.

Also known as: Tractocile

Group 1 - Atosiban

Atosiban and nifedipine DRUG

This group were given simultaneously as follows:Atosiban was given as a bolus (6.7 mg. IV) over 1 min then an infusion of 18 mg/hr for 3 hrs followed by 6 mg/hr for 48 hrs.Nifedipine was given in the dose of 10 mg orally every 15 min till uterine quiescence was achieved (\<4 contractions/hr). Maximum dose was 40 mg in the first hour then maintenance dose of 10 mg every 4-6 h for 48 hrs was given.

Also known as: Tractocile and nifedipine

Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of preterm labour
• Women with singleton pregnancies

You may not qualify if:

• Women with preterm prelabour rupture of membranes
• Women with any indication for emergency delivery for whom prolongation of pregnancy is contraindicated

Sponsors & Collaborators

• Tawam Hospital: lead

Study Sites (2)

Department of obstetrics and Gynecology, Tawam Hospital

Al Ain City, Abudhabi, 15258, United Arab Emirates

Location

Tawam Hospital

Al Ain City, Abudhabi, 15258, United Arab Emirates

Location

Related Publications (3)

• Vogel JP, Nardin JM, Dowswell T, West HM, Oladapo OT. Combination of tocolytic agents for inhibiting preterm labour. Cochrane Database Syst Rev. 2014 Jul 11;2014(7):CD006169. doi: 10.1002/14651858.CD006169.pub2.

  PMID: 25010869 BACKGROUND

• Doret M, Mellier G, Gaucherand P, Saade GR, Benchaib M, Frutoso J, Pasquier JC. The in vitro effect of dual combinations of ritodrine, nicardipine and atosiban on contractility of pregnant rat myometrium. BJOG. 2003 Aug;110(8):731-4.

  PMID: 12892684 RESULT

• 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

Related Links

• RCOG Guidelines No.1 (B) February 2011. Tocolytic drugs for women in preterm labour.

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

atosiban; Nifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Wafa R AlOmari

  Tawam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrics and gynecolgy

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 7, 2011
• Study Start: April 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

AE (2)