Placenta PreviaNCT03779438
17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa
A study testing 17-OHPC in people with Placenta Previa, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 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
- Estimated gestational age: between 24 weeks and 37 week's gestation
- Confirmed Placenta previa; either major or minor degrees.
- Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding
Who cannot join
- Severe attack of bleeding requiring an immediate intervention.
- Fetal heart rates instability or non-reassuring tracing
- Intrauterine fetal death or major fetal anomalies.
- If associated with abruptio placentae
- Patients with known bleeding disorders or on anticoagulant therapy
- Patients with severe medical disorders
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: Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study
Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with Placenta Previa
Read the detailed description
Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa.
The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth.
Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa.
The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.
- Conditions
- Placenta Previa
- Being tested
- 17-OHPC, placebo to 17-OHPC
- Keywords
- cesarean section, placenta previa, antepartum hemorrhage, 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
patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
placebo to 17-OHPCDrug
Also called Placebo Comparator
patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' 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 24-26 week and up to 37-weeks' gestation or delivery Receives: Drug: 17-OHPC |
| placebo to 17-OHPC | Placebo comparator | patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery Receives: Drug: placebo to 17-OHPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery
Measured: 6 weeks
Secondary outcomes (2)
apgar score
measure apgar score from 0 to 10
Measured: 5 minutes postpartum
the number of patients with postpartum hemorrhage
calculation the number of patients with postpartum hemorrhage
Measured: 24 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 Mar 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 Double-Blind Randomized Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 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
- NCT03779438
- Sponsor's protocol ID
- aswu/189/18
- 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
- Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03779438
- Acronym / sponsor ID
- aswu/189/18
- Conditions
- Placenta Previa
- Keywords
- cesarean section, placenta previa, antepartum hemorrhage, 17-alpha-Hydroxyprogesterone caproate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 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 Mar 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 intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with Placenta Previa
Detailed description
Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa.
The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth.
Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa.
The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-Blind Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| 17-OHPC | Active comparator | Drug: 17-OHPCpatients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery |
| placebo to 17-OHPC | Placebo comparator | Drug: placebo to 17-OHPCpatients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Estimated gestational age: between 24 weeks and 37 week's gestation
- Confirmed Placenta previa; either major or minor degrees.
- Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding
Key exclusion criteria (6 listed)
- Severe attack of bleeding requiring an immediate intervention.
- Fetal heart rates instability or non-reassuring tracing
- Intrauterine fetal death or major fetal anomalies.
- If associated with abruptio placentae
- Patients with known bleeding disorders or on anticoagulant therapy
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 depotpatients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery | Drug | 17-OHPC |
| placebo to 17-OHPCAlso: Placebo Comparatorpatients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery | Drug | placebo to 17-OHPC |
Primary outcome
the duration of prolongation of pregnancy from the time of enrollment to the time of delivery
Time frame: 6 weeks
measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery
2 secondary outcomes
apgar score
Time frame: 5 minutes postpartum
the number of patients with postpartum hemorrhage
Time frame: 24 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
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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.
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 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 3 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 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. 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 hany f sallam (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?
the duration of prolongation of pregnancy from the time of enrollment to the time of delivery (time frame: 6 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 15 Feb 2019.