Placenta PreviaNCT03779451
Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa
A study testing 17-OHPC and vaginal progesterone in people with Placenta Previa, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- 17-OHPC and vaginal progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Apr 2022
- 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 18 to 45 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 the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan
Who cannot join
- Multiple pregnancies.
- Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour 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
Aswan University
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
Nahla w Shady, md, 1019240504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study
Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa
Read the detailed description
The study will be a randomized open-label clinical trial conducted at a tertiary university hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between January 2019 and March 2022. The authors will include women who asymptomatic pregnant women with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group III(control group). In each group, Follow-up visits were performed every week then admission was done at 36 weeks at our university hospital. Scheduled caesarian section was done at completed 37 weeks unless otherwise required.
- Conditions
- Placenta Previa
- Being tested
- 17-OHPC, vaginal progesterone
- Keywords
- cesarean section, placenta previa, antepartum hemorrhage, vaginal progesterone, 17-Alpha-Hydroxyprogesterone Caproate
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-OHPCDrug
Also called Active Comparator, cidolut depot
received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery.
vaginal progesteroneDrug
Also called Active Comparator, Cyclogest
vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery
| Study group | Role | What they receive |
|---|---|---|
| 17-OHPC | Active comparator | patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery Receives: Drug: 17-OHPC |
| vaginal progesterone | Active comparator | vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery 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.
number of patient delivered before 37 weeks
calculation the number of patients delivered before 37 weeks
Measured: 2 month
Secondary outcomes (3)
number of episodes of antepartum hemorrhage
calculating the mean number of episodes of antepartum hemorrhage
Measured: 2 month
Hospital admission for significant antepartum hemorrhage
Number of patients requiring hospital admission for significant antepartum hemorrhage
Measured: 2 month
Neonatal Birth weight
measure Neonatal Birth weight in kilograms
Measured: one hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Apr 2022 (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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779451
- Sponsor's protocol ID
- aswu/191/18
- Status last verified
- Feb 2019
- First submitted
- 15 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03779451
- Acronym / sponsor ID
- aswu/191/18
- Conditions
- Placenta Previa
- Keywords
- cesarean section, placenta previa, antepartum hemorrhage, vaginal progesterone, 17-Alpha-Hydroxyprogesterone Caproate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 19 Dec 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.
Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa
Detailed description
The study will be a randomized open-label clinical trial conducted at a tertiary university hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between January 2019 and March 2022. The authors will include women who asymptomatic pregnant women with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group III(control group). In each group, Follow-up visits were performed every week then admission was done at 36 weeks at our university hospital. Scheduled caesarian section was done at completed 37 weeks unless otherwise required.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| 17-OHPC | Active comparator | Drug: 17-OHPCpatients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery |
| vaginal progesterone | Active comparator | Drug: vaginal progesteronevaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery |
| 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 45 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 the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan
Key exclusion criteria (4 listed)
- Multiple pregnancies.
- Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour 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 |
|---|---|---|
| 17-OHPCAlso: Active Comparator, cidolut depotreceived weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery. | Drug | 17-OHPC |
| vaginal progesteroneAlso: Active Comparator, Cyclogestvaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery | Drug | vaginal progesterone |
Primary outcome
number of patient delivered before 37 weeks
Time frame: 2 month
calculation the number of patients delivered before 37 weeks
3 secondary outcomes
number of episodes of antepartum hemorrhage
Time frame: 2 month
Hospital admission for significant antepartum hemorrhage
Time frame: 2 month
Neonatal Birth weight
Time frame: one hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Placenta Previa
Not yet recruiting
ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
Placenta Previa
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
RecruitingObservational study
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
Antenatal Care, Maternal Health
Recruiting
Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia
Placenta Previa
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.
hany f sallam, md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 17-OHPC and vaginal progesterone in people with Placenta Previa, run by Aswan University Hospital 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 15 Feb 2019. 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.
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 hany f sallam, md (01022336052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patient delivered before 37 weeks (time frame: 2 month). 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 15 Feb 2019.