Estradiol Pretreatment With Misoprostol in Second Trimest... | NCT03479879

Studies
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

NCT03479879

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 29, 2019Actual

Enrollment

200Actual

Phase

Phase 2Phase 3

Conditions

Miscarriage

Interventions

Estradiol
Placebo Oral Tablet
Misoprostol

Countries

Egypt

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2018Actual

Primary Completion Date

Dec 20, 2018Actual

Completion Date

Dec 20, 2018Actual

First Submitted Date

Mar 21, 2018

First Submission Date that Met QC Criteria

Mar 21, 2018

First Posted Date

Mar 27, 2018Actual

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

Jan 26, 2019

Last Update Posted Date

Jan 29, 2019Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.

Detailed Description

Not provided

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Estradiol + Misoprostol	Experimental		Drug: Estradiol Drug: Misoprostol
Placebo + Misoprostol	Placebo Comparator		Drug: Placebo Oral Tablet Drug: Misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Estradiol	Drug	Estradiol	Estradiol + Misoprostol
Placebo Oral Tablet

Measure	Description	Time Frame
Duration of induction of abortion		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Maternal age more than 18 years old (age of legal consent).
Gestational age between 12-26 weeks.
Hb level > 10 g/dL.
BMI between 25 kg/m2 and 35 kg/m2.
Missed abortion.
Living fetus with multiple congenital malformations incompatible with life.
PPROMS with drained liquor and parents are consenting for termination of pregnancy.

Exclusion Criteria:

Maternal age less than 18 years old.
Gestational age less than 12 weeks or more than 26 weeks.
Hb level < 10 g/dL.
Scared uterus (previous myomectomy - cesarean section - hysterectomy and ruptured uterus).
Polyhydramnios.
Anencephaly.
Fibroid uterus.
BMI less than 25 kg/m2 and more than 35 kg/m2.
Coagulopathy.
Previous attempts for induction of abortion in the current pregnancy.
Allergy to misoprostol or estradiol.
Placenta previa.
Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Maternity Hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000022	Abortion, Spontaneous

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004958	Estradiol
D016595	Misoprostol

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided