Preterm LaborPhase 4NCT03343795
Oral Versus Parental Progesterone in the Management of Preterm Labor
A Phase 4 study testing oral progesterone and intramuscular progesterone in people with Preterm Labor, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- oral progesterone and intramuscular progesterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2017to 30 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Past history of one or more spontaneous preterm labor.
- Singleton pregnancy.
- Pregnancy of less than 20 weeks of gestation
Who cannot join
- Women on tocolytic drugs .
- Underwent cervical cerclage in this pregnancy .
- Multiple gestations .
- Major fetal congenital malformations .
- Pregnancy 0f more than 20 weeks gestation .
Trial locations and contacts
1 site in 1 country.
About this study
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%)
- Conditions
- Preterm Labor
- Being tested
- oral progesterone, intramuscular progesterone
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral progesteroneDrug
daily
intramuscular progesteroneDrug
every week
| Study group | Role | What they receive |
|---|---|---|
| study group 1 | Experimental | oral progesterone Receives: Drug: oral progesterone |
| study group 2 | Active comparator | intramuscular progesterone Receives: Drug: intramuscular progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of preterm labor
number of women delivered before 37 weeks
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start5 Jul 2017
- Primary completion13 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343795
- Sponsor's protocol ID
- PPTL
- Status last verified
- Jun 2018
- First submitted
- 11 Nov 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Parental Progesterone in the Management of Preterm Labor
- ClinicalTrials.gov ID
- NCT03343795
- Acronym / sponsor ID
- PPTL
- Conditions
- Preterm Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 13 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group 1 | Experimental | Drug: oral progesteroneoral progesterone |
| study group 2 | Active comparator | Drug: intramuscular progesteroneintramuscular progesterone |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Past history of one or more spontaneous preterm labor.
- Singleton pregnancy.
- Pregnancy of less than 20 weeks of gestation
Key exclusion criteria (5 listed)
- Women on tocolytic drugs .
- Underwent cervical cerclage in this pregnancy .
- Multiple gestations .
- Major fetal congenital malformations .
- Pregnancy 0f more than 20 weeks gestation .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral progesteronedaily | Drug | study group 1 |
| intramuscular progesteroneevery week | Drug | study group 2 |
Primary outcome
the rate of preterm labor
Time frame: 10 weeks
number of women delivered before 37 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral progesterone and intramuscular progesterone in people with Preterm Labor, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of preterm labor (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.