---
title: Oral Versus Parental Progesterone in the Management of Preterm Labor
nct_id: NCT03343795
overall_status: COMPLETED
phase: PHASE4
sponsor: Assiut University
study_type: INTERVENTIONAL
primary_condition: Preterm Labor
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03343795.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03343795"
ct_last_update_post_date: 2018-06-27
last_seen_at: "2026-05-12T07:13:19.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Oral Versus Parental Progesterone in the Management of Preterm Labor

**NCT ID:** [NCT03343795](https://clinicaltrials.gov/study/NCT03343795)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Assiut University
- **Conditions:** Preterm Labor
- **Start Date:** 2017-07-05
- **Completion Date:** 2018-05-30
- **CT.gov Last Update:** 2018-06-27

## 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%)

## Eligibility

- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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:

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 .
```

## Arms

- **study group 1** (EXPERIMENTAL) — oral progesterone
- **study group 2** (ACTIVE_COMPARATOR) — intramuscular progesterone

## Interventions

- **oral progesterone** (DRUG) — daily
- **intramuscular progesterone** (DRUG) — every week

## Primary Outcomes

- **the rate of preterm labor** _(time frame: 10 weeks)_ — number of women delivered before 37 weeks

## Locations (1)

- Assiut Faculty of Medicine, Asyut, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.assiut faculty of medicine|asyut||egypt` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03343795*  
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