ClinicalTrials.gg
Sign In
CompletedNCT03343795Updated Jun 27, 2018

Oral Versus Parental Progesterone in the Management of Preterm Labor

A Phase 4 interventional study of oral progesterone and intramuscular progesterone in Preterm Labor, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2018-06-27.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2017, registered Nov 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
Female
01

Study 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%)

02

Conditions studied

  • Preterm Labor
03

In context

Obstetric Labor, Premature

242 studies on the registry are indexed under Obstetric Labor, Premature; 36 are open to participants now.

This study's enrollment of 80 is below the median of 111 across 148 interventional studies indexed under Obstetric Labor, Premature.

Browse Obstetric Labor, Premature studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Women on tocolytic drugs .
  2. Underwent cervical cerclage in this pregnancy .
  3. Multiple gestations .
  4. Major fetal congenital malformations .
  5. Pregnancy 0f more than 20 weeks gestation .
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    study group 1

    oral progesterone

    Drug: oral progesterone

  • Active comparator
    study group 2

    intramuscular progesterone

    Drug: intramuscular progesterone

Interventions

06

What researchers measure

Primary outcomes

  1. the rate of preterm labor

    number of women delivered before 37 weeks

    Time frame: 10 weeks

07

Study locations

1 site
  • Assiut Faculty of Medicine
    Assiut, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in May 2018, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 11, 2017
First posted
Nov 17, 2017
StartActual
Jul 5, 2017
Primary completionActual
May 13, 2018
CompletionActual
May 30, 2018
Last update
Jun 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03343795
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Abbas (Principal investigator, Assiut University) — Principal investigator
First posted
Nov 17, 2017
Start date
Jul 5, 2017
Primary completion
May 13, 2018
Completion
May 30, 2018
Last update
Jun 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Progesterone

Other studies in this condition

Obstetric Labor, Premature →

Other studies from this sponsor

Assiut University →

Start the discussion