NCT03930212

Brief Summary

To decide whether progesterone supplementation in threatened abortion is a sound practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

April 20, 2019

Last Update Submit

July 15, 2023

Conditions

Threatened AbortionProgesterone Resistance

Outcome Measures

Primary Outcomes (3)

  • relief of pain

    questionnaire fulfilled by patient with yes or no questions

    3 weeks

  • completion of pregnancy beyond 20 weeks

    passing the age 20 weeks

    12 weeks

  • Stoppage of bleeding

    Cessation of bleeding

    3 weeks

Secondary Outcomes (1)

  • abortion less than 20 weeks.

    12 weeks

Study Arms (2)

Progesterone

EXPERIMENTAL

received rectal progesterone suppositories 400 mg once daily

Drug: Progesterone

Control group

PLACEBO COMPARATOR

received placebo suppositories rectally once daily.

Drug: Placebos

Interventions

ProgesteroneDRUG

received rectal progesterone suppositories 400 mg once daily

Progesterone
PlacebosDRUG

received placebo suppositories rectally once daily.

Control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • threatened abortion diagnosed by history and ultrasound examination
  • singleton
  • viable fetus
  • gestational age \< 20 weeks
  • closed normal length cervix.

You may not qualify if:

  • short cervix \<2 cm Multiple pregnancy
  • dead fetus
  • open cervix ≥ 2cm
  • history of cervical surgery
  • refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Egypt

Location

MeSH Terms

Conditions

Abortion, ThreatenedProgesterone Resistance

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 20, 2019

First Posted

April 29, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
2 months

Locations

EG(1)