Threatened AbortionPhase 4ProthreatNCT03930212
Progesterone Supplementation in Threatened Abortion
A Phase 4 study testing Progesterone in people with Threatened Abortion and Progesterone Resistance, run by Tanta University at 1 site in Egypt.
Trial summary
To decide whether progesterone supplementation in threatened abortion is a sound practice. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Threatened Abortion, Progesterone Resistance
- What is being tested?
- Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 31 Dec 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- threatened abortion diagnosed by history and ultrasound examination
- singleton
- viable fetus
- gestational age < 20 weeks
- closed normal length cervix.
Who cannot join
- short cervix <2 cm Multiple pregnancy
- dead fetus
- open cervix ≥ 2cm
- history of cervical surgery
- refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?
To decide whether progesterone supplementation in threatened abortion is a sound practice.
Read the detailed description
This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).
- Conditions
- Threatened Abortion, Progesterone Resistance
- Being tested
- Progesterone, Placebos
- Medical subject headings
- Abortion, Threatened, Progesterone Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
received rectal progesterone suppositories 400 mg once daily
PlacebosDrug
received placebo suppositories rectally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone | Experimental | received rectal progesterone suppositories 400 mg once daily Receives: Drug: Progesterone |
| Control group | Placebo comparator | received placebo suppositories rectally once daily. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
relief of pain
questionnaire fulfilled by patient with yes or no questions
Measured: 3 weeks
completion of pregnancy beyond 20 weeks
passing the age 20 weeks
Measured: 12 weeks
Stoppage of bleeding
Cessation of bleeding
Measured: 3 weeks
Secondary outcomes (1)
abortion less than 20 weeks.
Abortion
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened AbortionStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930212
- Sponsor's protocol ID
- Prog133077
- Acronym
- Prothreat
- Status last verified
- Jul 2023
- First submitted
- 20 Apr 2019
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?
- ClinicalTrials.gov ID
- NCT03930212
- Acronym / sponsor ID
- Prothreat / Prog133077
- Conditions
- Threatened Abortion, Progesterone Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Apr 2019 (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.
To decide whether progesterone supplementation in threatened abortion is a sound practice.
Detailed description
This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progesterone | Experimental | Drug: Progesteronereceived rectal progesterone suppositories 400 mg once daily |
| Control group | Placebo comparator | Drug: Placebosreceived placebo suppositories rectally once daily. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- threatened abortion diagnosed by history and ultrasound examination
- singleton
- viable fetus
- gestational age < 20 weeks
- closed normal length cervix.
Key exclusion criteria (5 listed)
- short cervix <2 cm Multiple pregnancy
- dead fetus
- open cervix ≥ 2cm
- history of cervical surgery
- refusal to participate.
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 |
|---|---|---|
| Progesteronereceived rectal progesterone suppositories 400 mg once daily | Drug | Progesterone |
| Placebosreceived placebo suppositories rectally once daily. | Drug | Control group |
Primary outcome
relief of pain
Time frame: 3 weeks
questionnaire fulfilled by patient with yes or no questions
completion of pregnancy beyond 20 weeks
Time frame: 12 weeks
passing the age 20 weeks
Stoppage of bleeding
Time frame: 3 weeks
Cessation of bleeding
1 secondary outcome
abortion less than 20 weeks.
Time frame: 12 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 18 Jul 2023.
- Individual participant dataSharing planned: Yes
Related trials for Threatened Abortion
Not yet recruitingObservational study
Serum Progesterone and Threatened Abortion During Lactation
Threatened Abortion
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 Progesterone in people with Threatened Abortion and Progesterone Resistance, run by Tanta 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 5 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 18 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
relief of pain (time frame: 3 weeks). The study lists 3 primary outcomes in all. 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 18 Jul 2023.