NCT03267771

Brief Summary

Recurrent pregnancy loss is classically defined as the occurrence of three or more consecutive pregnancy loss. The American Society of Reproductive Medicine has recently redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on an ultrasound or that pregnancy tissue was identified after a pregnancy loss.

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
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2017

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

June 5, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

June 5, 2017

Last Update Submit

September 6, 2017

Conditions

Abortion in First Trimester

Outcome Measures

Primary Outcomes (1)

  • number of Live births after 28 weeks of gestation

    Live births that survive and continue beyond 28 weeks of gestation

    28 weeks gestation

Secondary Outcomes (1)

  • Number of patients who Tolerable with the treatment

    12 weeks

Study Arms (2)

progesterone suppositories vaginal group

ACTIVE COMPARATOR

vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation.

Drug: Progesterone Suppositories VaginalDevice: doppler ultrasound

Dydrogesterone oral tablets group

EXPERIMENTAL

20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation.

Drug: Dydrogesterone Oral TabletDevice: doppler ultrasound

Interventions

Progesterone Suppositories VaginalDRUG

progesterone vaginal suppository

Also known as: Prontogest
progesterone suppositories vaginal group
Dydrogesterone Oral TabletDRUG

oral progesterone drug

Also known as: Duphaston
Dydrogesterone oral tablets group
doppler ultrasoundDEVICE

pulsed doppler ultrasound

Also known as: Gomez et al
Dydrogesterone oral tablets groupprogesterone suppositories vaginal group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant 7-12 weeks documented by pregnancy test \&/or ultrasaound.
  • History of at least 2 prior spontaneous abortion before 12 weeks of gestation.
  • Age: 18-35 years
  • Willing and able to give informed consent.
  • Rh +ve patient
  • BMI: 18-32
  • Viable pregnancy through the detection of fetal pulsations by ultrasound
  • Singleton pregnancy
  • Apparently stable pregnancy (no history of vaginal bleeding in this current pregnancy or signs of sac separation in ultrasound)

You may not qualify if:

  • Patients diagnosed to have Anti-phospholipid syndrome or another recognised thrombophilic or autoimmune conditions.
  • Pregnant \> 12 weeks.
  • Contraindication to progesterone use.
  • Diabetic patients, have glucose intolerance.
  • Multiple pregnancies.
  • Thyroid disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gehad Elsherief

Asyut, Egypt

Location

Related Publications (2)

  • Macklon NS, Geraedts JP, Fauser BC. Conception to ongoing pregnancy: the 'black box' of early pregnancy loss. Hum Reprod Update. 2002 Jul-Aug;8(4):333-43. doi: 10.1093/humupd/8.4.333.

    PMID: 12206468BACKGROUND

  • Sotiriadis A, Papatheodorou S, Makrydimas G. Threatened miscarriage: evaluation and management. BMJ. 2004 Jul 17;329(7458):152-5. doi: 10.1136/bmj.329.7458.152. No abstract available.

    PMID: 15258071BACKGROUND

MeSH Terms

Interventions

DydrogesteroneUltrasonography, Doppler

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsUltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Ahmed Ibrahim

CONTACT

01000024321ahmedibrahimhas@yahoo.com

Hesham Abu taleb

CONTACT

01003332139Hishamaboutaleb1@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicipal investigator

Study Record Dates

First Submitted

June 5, 2017

First Posted

August 30, 2017

Study Start

October 1, 2017

Primary Completion

August 5, 2019

Study Completion

December 5, 2019

Last Updated

September 8, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)