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Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial (UTROGESTAN)

Primary Purpose

Preterm Labor

Status
Unknown status
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
utrogestan
Nifedipine
Sponsored by
nor zila hassan malek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Labor focused on measuring preterm labor

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

• Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.

Exclusion Criteria:

  • Multiple pregnancies
  • Women with Preterm Prelabour Rupture of Membrane
  • Fetal death
  • Women with bad obstetric history
  • Women with history of cervical incompetence
  • Contraindication to Nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to Utrogestan
  • Maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta
  • Contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage
  • Cervical dilatation of 3cm or more
  • Patients with previous tocolytic treatment during this pregnancy
  • Women who refuse to participate in this study

Sites / Locations

  • Obstetric and Gynaecology Department, National University of Malaysia Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Utrogestan

Nifedipine

Arm Description

oral tablet Utrogestan 400mg daily for 2 days

tablet Nifedipine 20 mg stat then 20 mg after 30 minutes then another 20 mg after 30 minutes followed by 10 mg three times daily for 2 days

Outcomes

Primary Outcome Measures

latency period interval between time of tocolysis and delivery
delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis

Secondary Outcome Measures

Pregnancy outcomes
delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation
Neonatal outcome
Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission
Maternal side effect
Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus

Full Information

First Posted
November 4, 2013
Last Updated
November 10, 2013
Sponsor
nor zila hassan malek
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1. Study Identification

Unique Protocol Identification Number
NCT01985594
Brief Title
Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial
Acronym
UTROGESTAN
Official Title
STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
nor zila hassan malek

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RESEARCH HYPOTHESIS -Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
preterm labor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Utrogestan
Arm Type
Active Comparator
Arm Description
oral tablet Utrogestan 400mg daily for 2 days
Arm Title
Nifedipine
Arm Type
Placebo Comparator
Arm Description
tablet Nifedipine 20 mg stat then 20 mg after 30 minutes then another 20 mg after 30 minutes followed by 10 mg three times daily for 2 days
Intervention Type
Drug
Intervention Name(s)
utrogestan
Intervention Description
Oral Tablet Utrogestan 400 mg daily for 2 days
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
Tablet Nifedipine 20 mg stat then 20 mg after 30 minutes if contraction persist and another 20mg after 30 minutes if contraction still persist followed by 10 mg three times daily for 2 days
Primary Outcome Measure Information:
Title
latency period interval between time of tocolysis and delivery
Description
delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis
Time Frame
24 hours up to 7 days
Secondary Outcome Measure Information:
Title
Pregnancy outcomes
Description
delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation
Time Frame
34 weeks of gestational age
Title
Neonatal outcome
Description
Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission
Time Frame
24 hours
Title
Maternal side effect
Description
Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus
Time Frame
30 minutes up to 48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor. Exclusion Criteria: Multiple pregnancies Women with Preterm Prelabour Rupture of Membrane Fetal death Women with bad obstetric history Women with history of cervical incompetence Contraindication to Nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to Utrogestan Maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta Contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage Cervical dilatation of 3cm or more Patients with previous tocolytic treatment during this pregnancy Women who refuse to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nor zila hassan malek
Phone
60139823219
Email
nzhm_dr@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nor azlin mohamed ismail
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obstetric and Gynaecology Department, National University of Malaysia Medical Centre
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
national university of malaysia medical centre
Phone
60391455950
First Name & Middle Initial & Last Name & Degree
nor zila hassan malek
First Name & Middle Initial & Last Name & Degree
nor azlin mohamed ismail

12. IPD Sharing Statement

Citations:
PubMed Identifier
35947046
Citation
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.
Results Reference
derived

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Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial

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