NCT05542797

Brief Summary

In this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2022

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

September 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 9, 2022

Last Update Submit

September 13, 2022

Conditions

Miscarriage Threatening

Outcome Measures

Primary Outcomes (1)

  • Miscarriage rate

    Effects of two drugs to be used on live birth rate in pregnant women with threated miscarriage

    One year

Study Arms (2)

Micronised progesterone

EXPERIMENTAL

Micronized progesterone will be given to 70 pregnant women with threated miscarriage.

Drug: Duphastone

Dydrogesterone

EXPERIMENTAL

Dydrogesterone will be given to 70 pregnant women with threated miscarriage.

Drug: Duphastone

Interventions

DuphastoneDRUG

dydrogesterone hormone

DydrogesteroneMicronised progesterone

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women with threated miscarriage in the first trimester.

You may not qualify if:

  • \- pregnant women with abortus incipiens.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abortion, Threatened

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
obstetrics and gynecology

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 15, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

November 1, 2024

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share