NCT03343795

Brief Summary

Preterm birth, defined as delivery at less than 37 weeks gestation, complicates approximately 12% of pregnancies in the United States Preterm delivery has been, and remains, the most important challenge to modern obstetrics. In 2009, 13 million babies were born preterm, 11 million in Africa and Asia and 500,000 in the USA, The highest rates of preterm birth are in Africa (11.9%) and North America (10.6%)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2017

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

July 5, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

November 11, 2017

Last Update Submit

June 26, 2018

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

  • the rate of preterm labor

    number of women delivered before 37 weeks

    10 weeks

Study Arms (2)

study group 1

EXPERIMENTAL

oral progesterone

Drug: oral progesterone

study group 2

ACTIVE COMPARATOR

intramuscular progesterone

Drug: intramuscular progesterone

Interventions

oral progesteroneDRUG

daily

study group 1
intramuscular progesteroneDRUG

every week

study group 2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Past history of one or more spontaneous preterm labor.
  • Singleton pregnancy.
  • Pregnancy of less than 20 weeks of gestation

You may not qualify if:

  • Women on tocolytic drugs .
  • Underwent cervical cerclage in this pregnancy .
  • Multiple gestations .
  • Major fetal congenital malformations .
  • Pregnancy 0f more than 20 weeks gestation .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy 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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 11, 2017

First Posted

November 17, 2017

Study Start

July 5, 2017

Primary Completion

May 13, 2018

Study Completion

May 30, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

EG(1)