NCT01985594

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

November 4, 2013

Last Update Submit

November 10, 2013

Conditions

Preterm Labor

Keywords

preterm labor

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours up to 7 days

Secondary Outcomes (3)

  • Pregnancy outcomes

    34 weeks of gestational age

  • Neonatal outcome

    24 hours

  • Maternal side effect

    30 minutes up to 48 hours

Study Arms (2)

Utrogestan

ACTIVE COMPARATOR

oral tablet Utrogestan 400mg daily for 2 days

Drug: utrogestan

Nifedipine

PLACEBO COMPARATOR

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

Drug: Nifedipine

Interventions

utrogestanDRUG

Oral Tablet Utrogestan 400 mg daily for 2 days

Utrogestan
NifedipineDRUG

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

Nifedipine

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetric and Gynaecology Department, National University of Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

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: 35947046DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

UtrogestanNifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • nor azlin mohamed ismail

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

nor zila hassan malek

CONTACT

60139823219nzhm_dr@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
medical officer

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 15, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

MY(1)