Comparison of Dydrogesterone and Micronized Progesterone... | NCT05542797

Studies
Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.

NCT05542797

Sponsor

Konya Meram State Hospital

Status

Unknown status

Last Update Posted

Sep 15, 2022Actual

Enrollment

140Estimated

Phase

Phase 4

Conditions

Miscarriage Threatening

Interventions

Duphastone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2022Estimated

Primary Completion Date

Oct 2023Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Sep 9, 2022

First Submission Date that Met QC Criteria

Sep 13, 2022

First Posted Date

Sep 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2022

Last Update Posted Date

Sep 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hasan Ali Inal, MD, obstetrics and gynecology, Konya Meram State HospitalPrincipal Investigator

Lead Sponsor

Konya Meram State HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

About 140 pregnant women who applied to our clinic due to the threated miscarriage in the first trimester will be randomly given micronized progesterone to half and dydrogesterone to the other half. After the treatment, the miscarriage rates in the groups will be compared.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Duphastone	Drug	dydrogesterone hormone	Dydrogesterone Micronised progesterone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Miscarriage rate	Effects of two drugs to be used on live birth rate in pregnant women with threated miscarriage	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women with threated miscarriage in the first trimester.

Exclusion Criteria:

- pregnant women with abortus incipiens.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000033	Abortion, Threatened

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

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