Placenta PreviaPhase 2NCT03633175
Progesterone in Patients With Placenta Previa
A Phase 2 study testing Vaginal progesterone in people with Placenta Previa, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Vaginal progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2018to Aug 2019
- Phase
- Phase 2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age 26-28 weeks of gestation.
- Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan.
Who cannot join
- Multiple pregnancy.
- Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM).
- Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
- Women who have been maintained on progestin therapy since early pregnancy for whatever reason.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain SHams Maternity Hospital
Cairo, Abbaseya, 002
Mohamed Samy, MD, 01001947488, mohammedsamy8132@gmail.com
About this study
Official title: Efficacy of Prophylactic Vaginal Progesterone in Prevention of Preterm Delivery in Women With Placenta Previa
This study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa.
Read the detailed description
Eligible women who consent to participate in the study are randomly allocated into one of the two study groups. Women who are allocated to the study group will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. Patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.
- Conditions
- Placenta Previa
- Being tested
- Vaginal progesterone
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal progesteroneDrug
Also called Prontogest® suppositories
400 mg vaginal progesterone [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt] will be given, once at bed time starting from 26-28 weeks of gestation till 36 weeks of gestation or delivery (which is closer).
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone group | Active comparator | Women will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer). Receives: Drug: Vaginal progesterone |
| Control group | No intervention | Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preterm delivery due to severe antepartum hemorrhage.
Number of patients who delivered before 37 weeks gestational age
Measured: from 26 weeks till 37 weeks
Secondary outcomes (12)
No. of episodes of antepartum hemorrhage.
Mean number of episodes of antepartum hemorrhage
Measured: from 26 weeks till 37 weeks
Hospital admission for significant antepartum hemorrhage.
Number of patients requiring hospital admission for significant antepartum hemorrhage
Measured: from 26 weeks till 37 weeks
Hospital admission for threatened preterm labor.
Number of patients requiring hospital admission for threatened preterm labor
Measured: from 26 weeks till 37 weeks
Need for blood transfusion.
Number of patients requiring blood transfusion
Measured: from 26 weeks till 37 weeks
Incidence of severe postpartum hemorrhage.
Number of patients who had severe postpartum hemorrhage
Measured: from 26 weeks till 37 weeks
Incidence of Cesarean hysterectomy.
Number of patients who underwent cesarean hysterectomy
Measured: from 26 weeks till 37 weeks
Patient compliance
measured as mean number of doses of vaginal progesterone missed per week
Measured: from 26 weeks till 37 weeks
Patient satisfaction: Likert Scale
measured according to the 5-grade Likert scale: very unsatisfied, unsatisfied, indifferent, satisfied and very satisfied.
Measured: from 26 weeks till 37 weeks
Neonatal Birth weight.
measured in Kg
Measured: At birth
Need for NICU admission and its duration.
Number of neonates needing NICU admission
Measured: At birth
Respiratory morbidity (transient tachypnea or respiratory distress syndrome).
number of neonates with respiratory morbidities (transient tachypnea or respiratory distress syndrome).
Measured: At birth
Prematurity-related mortality.
Number of neonates dying due to prematurity-related cause
Measured: 28 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start5 Jul 2018
- Primary completionJul 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed mahmoud samy, Ain Shams University
- Investigators
- Mohamed Samy, MD, Principal investigator, M Samy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633175
- Sponsor's protocol ID
- progesterone
- Status last verified
- Aug 2018
- First submitted
- 30 Jun 2016
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prophylactic Vaginal Progesterone in Prevention of Preterm Delivery in Women With Placenta Previa
- ClinicalTrials.gov ID
- NCT03633175
- Acronym / sponsor ID
- progesterone
- Conditions
- Placenta Previa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 16 Aug 2018 (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.
This study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa.
Detailed description
Eligible women who consent to participate in the study are randomly allocated into one of the two study groups. Women who are allocated to the study group will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. Patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone group | Active comparator | Drug: Vaginal progesteroneWomen will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer). |
| Control group | No intervention | –Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Gestational age 26-28 weeks of gestation.
- Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan.
Key exclusion criteria (4 listed)
- Multiple pregnancy.
- Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM).
- Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
- Women who have been maintained on progestin therapy since early pregnancy for whatever reason.
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 progesteroneAlso: Prontogest® suppositories400 mg vaginal progesterone [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt] will be given, once at bed time starting from 26-28 weeks of gestation till 36 weeks of gestation or delivery (which is closer). | Drug | Vaginal progesterone group |
Primary outcome
Incidence of preterm delivery due to severe antepartum hemorrhage.
Time frame: from 26 weeks till 37 weeks
Number of patients who delivered before 37 weeks gestational age
12 secondary outcomes
No. of episodes of antepartum hemorrhage.
Time frame: from 26 weeks till 37 weeks
Hospital admission for significant antepartum hemorrhage.
Time frame: from 26 weeks till 37 weeks
Hospital admission for threatened preterm labor.
Time frame: from 26 weeks till 37 weeks
Need for blood transfusion.
Time frame: from 26 weeks till 37 weeks
Incidence of severe postpartum hemorrhage.
Time frame: from 26 weeks till 37 weeks
Incidence of Cesarean hysterectomy.
Time frame: from 26 weeks till 37 weeks
Patient compliance
Time frame: from 26 weeks till 37 weeks
Patient satisfaction: Likert Scale
Time frame: from 26 weeks till 37 weeks
Neonatal Birth weight.
Time frame: At birth
Need for NICU admission and its duration.
Time frame: At birth
Respiratory morbidity (transient tachypnea or respiratory distress syndrome).
Time frame: At birth
Prematurity-related mortality.
Time frame: 28 days postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- 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.
Mohamed Samy, MD principal investigator
M Samy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaginal progesterone in people with Placenta Previa, run by Ain Shams 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 2 inclusion and 4 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 16 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mohamed Samy, MD (01001947488, mohammedsamy8132@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preterm delivery due to severe antepartum hemorrhage. (time frame: from 26 weeks till 37 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 16 Aug 2018; AzTrials last refreshed its copy on 4 Nov 2026.