Abortion in First TrimesterPhase 4NCT03267771
Progesterone and Doppler in Recurrent Abortion
A Phase 4 study testing Progesterone Suppositories Vaginal, Dydrogesterone Oral Tablet and doppler ultrasound in people with Abortion in First Trimester, run by Assiut University at 1 site in Egypt.
Trial summary
Recurrent pregnancy loss is classically defined as the occurrence of three or more consecutive pregnancy loss. The American Society of Reproductive Medicine has recently redefined recurrent pregnancy loss as two or more pregnancy losses. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion in First Trimester
- What is being tested?
- Progesterone Suppositories Vaginal, Dydrogesterone Oral Tablet and doppler ultrasound
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 5 Dec 2019
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant 7-12 weeks documented by pregnancy test \&/or ultrasaound.
- History of at least 2 prior spontaneous abortion before 12 weeks of gestation.
- Age: 18-35 years
- Willing and able to give informed consent.
- Rh +ve patient
- BMI: 18-32
Show all 9Show fewer
- Viable pregnancy through the detection of fetal pulsations by ultrasound
- Singleton pregnancy
- Apparently stable pregnancy (no history of vaginal bleeding in this current pregnancy or signs of sac separation in ultrasound)
Who cannot join
- Patients diagnosed to have Anti-phospholipid syndrome or another recognised thrombophilic or autoimmune conditions.
- Pregnant > 12 weeks.
- Contraindication to progesterone use.
- Diabetic patients, have glucose intolerance.
- Multiple pregnancies.
- Thyroid disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Serum Progesterone and Doppler Ultrasound in Prediction of Pregnancy Outcome in Women With Recurrent Unexplained Abortion
Recurrent pregnancy loss is classically defined as the occurrence of three or more consecutive pregnancy loss. The American Society of Reproductive Medicine has recently redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on an ultrasound or that pregnancy tissue was identified after a pregnancy loss.
Read the detailed description
Spontaneous pregnancy loss is a surprisingly common occurrence. Whereas approximately 15% of all clinically recognized pregnancies result in spontaneous loss, there are many more pregnancies that fail prior to being clinically recognized. Only 30% of all conceptions result in a live birth.
Although no reliable published data have estimated the probability of finding an etiology for recurrent pregnancy loss in a population with 2 versus 3 or more miscarriages, the best available data suggest that the risk of miscarriage in subsequent pregnancies is 30% after 2 losses, compared with 33% after 3 losses among patients without a history of a live birth. This strongly suggests a role for evaluation after just 2 losses in patients with no prior live births. An earlier evaluation may be further indicated if fetal cardiac activity was identified prior to a loss .
- Conditions
- Abortion in First Trimester
- Being tested
- Progesterone Suppositories Vaginal, Dydrogesterone Oral Tablet, doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone Suppositories VaginalDrug
Also called Prontogest
progesterone vaginal suppository
Dydrogesterone Oral TabletDrug
Also called Duphaston
oral progesterone drug
doppler ultrasoundDevice
Also called Gomez et al
pulsed doppler ultrasound
| Study group | Role | What they receive |
|---|---|---|
| progesterone suppositories vaginal group | Active comparator | vaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation. Receives: Drug: Progesterone Suppositories Vaginal; Device: doppler ultrasound |
| Dydrogesterone oral tablets group | Experimental | 20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation. Receives: Drug: Dydrogesterone Oral Tablet; Device: doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Live births after 28 weeks of gestation
Live births that survive and continue beyond 28 weeks of gestation
Measured: 28 weeks gestation
Secondary outcomes (1)
Number of patients who Tolerable with the treatment
efficacy of treatment on patients
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 posted30 Aug 2017
- Study start1 Oct 2017 (estimated)
- Primary completion5 Aug 2019 (estimated)
- Study completion5 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abortion in First TrimesterStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GKElsherief, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267771
- Sponsor's protocol ID
- gehad elsherief
- Status last verified
- Sep 2017
- First submitted
- 5 Jun 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Macklon NS, Geraedts JP, Fauser BC. Conception to ongoing pregnancy: the 'black box' of early pregnancy loss. Hum Reprod Update. 2002 Jul-Aug;8(4):333-43. doi: 10.1093/humupd/8.4.333.
PubMed 12206468Sotiriadis A, Papatheodorou S, Makrydimas G. Threatened miscarriage: evaluation and management. BMJ. 2004 Jul 17;329(7458):152-5. doi: 10.1136/bmj.329.7458.152. No abstract available.
PubMed 15258071
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Serum Progesterone and Doppler Ultrasound in Prediction of Pregnancy Outcome in Women With Recurrent Unexplained Abortion
- ClinicalTrials.gov ID
- NCT03267771
- Acronym / sponsor ID
- gehad elsherief
- Conditions
- Abortion in First Trimester
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 5 Aug 2019 (estimated)
- Study completion
- 5 Dec 2019 (estimated)
- First posted
- 30 Aug 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.
Recurrent pregnancy loss is classically defined as the occurrence of three or more consecutive pregnancy loss. The American Society of Reproductive Medicine has recently redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on an ultrasound or that pregnancy tissue was identified after a pregnancy loss.
Detailed description
Spontaneous pregnancy loss is a surprisingly common occurrence. Whereas approximately 15% of all clinically recognized pregnancies result in spontaneous loss, there are many more pregnancies that fail prior to being clinically recognized. Only 30% of all conceptions result in a live birth.
Although no reliable published data have estimated the probability of finding an etiology for recurrent pregnancy loss in a population with 2 versus 3 or more miscarriages, the best available data suggest that the risk of miscarriage in subsequent pregnancies is 30% after 2 losses, compared with 33% after 3 losses among patients without a history of a live birth. This strongly suggests a role for evaluation after just 2 losses in patients with no prior live births. An earlier evaluation may be further indicated if fetal cardiac activity was identified prior to a loss .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progesterone suppositories vaginal group | Active comparator | Drug: Progesterone Suppositories Vaginal, Device: doppler ultrasoundvaginal micronized progesterone suppositories (prontogest®) 400 mg, one vaginal suppository twice daily through 18 weeks of gestation. |
| Dydrogesterone oral tablets group | Experimental | Drug: Dydrogesterone Oral Tablet, Device: doppler ultrasound20 mg tablets (Duphaston ®), 2 tablets orally twice daily through 18 weeks of gestation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- pregnant 7-12 weeks documented by pregnancy test \&/or ultrasaound.
- History of at least 2 prior spontaneous abortion before 12 weeks of gestation.
- Age: 18-35 years
- Willing and able to give informed consent.
- Rh +ve patient
Key exclusion criteria (6 listed)
- Patients diagnosed to have Anti-phospholipid syndrome or another recognised thrombophilic or autoimmune conditions.
- Pregnant > 12 weeks.
- Contraindication to progesterone use.
- Diabetic patients, have glucose intolerance.
- Multiple pregnancies.
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 |
|---|---|---|
| Progesterone Suppositories VaginalAlso: Prontogestprogesterone vaginal suppository | Drug | progesterone suppositories vaginal group |
| Dydrogesterone Oral TabletAlso: Duphastonoral progesterone drug | Drug | Dydrogesterone oral tablets group |
| doppler ultrasoundAlso: Gomez et alpulsed doppler ultrasound | Device | Dydrogesterone oral tablets group, progesterone suppositories vaginal group |
Primary outcome
number of Live births after 28 weeks of gestation
Time frame: 28 weeks gestation
Live births that survive and continue beyond 28 weeks of gestation
1 secondary outcome
Number of patients who Tolerable with the treatment
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Background: PubMed 12206468Macklon NS, Geraedts JP, Fauser BC. Conception to ongoing pregnancy: the 'black box' of early pregnancy loss. Hum Reprod Update. 2002 Jul-Aug;8(4):333-43. doi: 10.1093/humupd/8.4.333.
- Background: PubMed 15258071Sotiriadis A, Papatheodorou S, Makrydimas G. Threatened miscarriage: evaluation and management. BMJ. 2004 Jul 17;329(7458):152-5. doi: 10.1136/bmj.329.7458.152. No abstract available.
- Individual participant dataSharing planned: No
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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.
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 Suppositories Vaginal, Dydrogesterone Oral Tablet and doppler ultrasound in people with Abortion in First Trimester, 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 9 inclusion and 6 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 8 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Ibrahim (01000024321, ahmedibrahimhas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of Live births after 28 weeks of gestation (time frame: 28 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267771, which also lists 2 linked publications.
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 8 Sep 2017.