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Progesterone and Aminophylline for the Prevention of Preterm Labour

NCT03152942 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-02-28

No results posted yet for this study

Summary

The aim of this study is to investigate whether the combination of aminophylline and Progesterone (P4) is acceptable to women at high-risk of Pre-term labour (PTL). If this proves to be the case, a larger double blind, randomised controlled trial will be conducted to test the hypothesis that the combination of P4 and aminophylline reduces the risk of PTL more effectively than P4 alone.

The study is a randomised study where participants will be either administered a combination of aminophylline and Progesterone (P4) or Progesterone (P4) alone.As the study is open label, the participants and the study doctor will know which study medications the participant is taking at all times during the study.

Conditions

  • Premature Obstetric Labor

Interventions

DRUG

Progesterone

Progesterone 400mg to be administered once daily for 34 weeks in the patients randomised to receive progesterone alone

DRUG

Aminophylline

Patients randomised to the combination arm to be administered aminophylline 225 mg to be taken once at night for 1 week and then if tolerated increased to 225 mg twice daily Progesterone 400mg to be administered once daily for 34 weeks.

Sponsors & Collaborators

  • Action Medical Research

    collaborator OTHER

  • St Stephens Aids Trust

    lead OTHER

Principal Investigators

  • Mark Johnson, Professor · Chelsea and Westminster Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2018-10-31
Completion
2019-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03152942 on ClinicalTrials.gov