Threatened MiscarriageVPMNCT02690129
Vaginal Progesterone for Treatment of Threatened Miscarriage
A study testing Vaginal Progesteron in people with Threatened Miscarriage, run by Omar Mamdouh Shaaban at 1 site in Egypt.
Trial summary
The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Threatened Miscarriage
- What is being tested?
- Vaginal Progesteron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Feb 2018
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant with gestational age less than 24 weeks
- Presented by bleeding with or without pain
- Single viable fetus (confirmed by Ultrasound examination)
- Accepting to have vaginal medication
Who cannot join
- Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
- Hypersensitivity to progesterone
- Any documented congenital fetal anomaly in the current pregnancy
- Women received hormonal treatment in the current pregnancy
- Patients conceived via ART
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Asyut, Asyut Governorate
Hany Abdel-Aleem, MD
Omar M Shaaban, MD
About this study
Official title: Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial
The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.
- Conditions
- Threatened Miscarriage
- Being tested
- Vaginal Progesteron
- Keywords
- progesterone, threatened abortion
- Medical subject headings
- Abortion, Threatened
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal ProgesteronDrug
Also called Progesterone
| Study group | Role | What they receive |
|---|---|---|
| Group I (Progesterone Group) | Active comparator | Complete bed rest as an in/or out- patient, according to patient's preference for first 48-72 hours.
* Vaginal progesterone treatment as single daily dose of natural micronized progesterone (Prontogest ® 200 mg) at bedtime for 15 days.
* If needed, a pain killer as Indomethacin 50 mg/ rectally twice daily up to control of uterine colic .
* Complete abstaining from sexual activity or strenuous effort. Additionally, Rh-ve women with established viable fetuses and continue bleeding will be given a shot of anti-D immunoglobulin 300 ugm/IM ; after 12 weeks' gestation or if undergo surgical evacuation. Receives: Drug: Vaginal Progesteron |
| Group II ( Control group) | Placebo comparator | Will follow the same plan of management without progesterone support. Receives: Drug: Vaginal Progesteron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miscarriage rate up to 28 weeks of gestation
Measured: Completed 28th week
Secondary outcomes (1)
Gestational age at delivery or termination of pregnancy
Measured: Number of completed weeks at the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened MiscarriageStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omar Mamdouh Shaaban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Mamdouh Shaaban, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690129
- Sponsor's protocol ID
- treatment of miscarraige
- Acronym
- VPM
- Status last verified
- Feb 2016
- First submitted
- 19 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02690129
- Acronym / sponsor ID
- VPM / treatment of miscarraige
- Conditions
- Threatened Miscarriage
- Keywords
- progesterone, threatened abortion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Omar Mamdouh ShaabanUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- 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.
The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Progesterone Group) | Active comparator | Drug: Vaginal ProgesteronComplete bed rest as an in/or out- patient, according to patient's preference for first 48-72 hours. * Vaginal progesterone treatment as single daily dose of natural micronized progesterone (Prontogest ® 200 mg) at bedtime for 15 days. * If needed, a pain killer as Indomethacin 50 mg/ rectally twice daily up to control of uterine colic . * Complete abstaining from sexual activity or strenuous effort. Additionally, Rh-ve women with established viable fetuses and continue bleeding will be given a shot of anti-D immunoglobulin 300 ugm/IM ; after 12 weeks' gestation or if undergo surgical evacuation. |
| Group II ( Control group) | Placebo comparator | Drug: Vaginal ProgesteronWill follow the same plan of management without progesterone support. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant with gestational age less than 24 weeks
- Presented by bleeding with or without pain
- Single viable fetus (confirmed by Ultrasound examination)
- Accepting to have vaginal medication
Key exclusion criteria (5 listed)
- Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
- Hypersensitivity to progesterone
- Any documented congenital fetal anomaly in the current pregnancy
- Women received hormonal treatment in the current pregnancy
- Patients conceived via ART
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 |
|---|---|---|
| Vaginal ProgesteronAlso: Progesterone | Drug | Group I (Progesterone Group), Group II ( Control group) |
Primary outcome
Miscarriage rate up to 28 weeks of gestation
Time frame: Completed 28th week
1 secondary outcome
Gestational age at delivery or termination of pregnancy
Time frame: Number of completed weeks at the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Threatened Miscarriage
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Progesteron in people with Threatened Miscarriage, run by Omar Mamdouh Shaaban 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 4 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: status not confirmed, as of the sponsor's last update on 24 Feb 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar M Shaaban, MD (+201223971457, omshaaban2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miscarriage rate up to 28 weeks of gestation (time frame: Completed 28th week). 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 24 Feb 2016.