Preterm LaborPhase 2NCT03130504
Intramuscular Hydroxyprogesterone Caproate and Placenta Previa
A Phase 2 study testing 17α hydroxy progesterone caproate in people with Preterm Labor, run by Assiut University at 1 site in Egypt.
Trial summary
Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- 17α hydroxy progesterone caproate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2016to Apr 2017
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Estimated gestational age is ranging between 24 weeks and 26 week's gestation
- Singleton pregnancy.
- Placenta previa; either major or minor degrees.
- Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
- For outpatient follow ups, women should be living in a nearby area to make follow-up and early transportation are reasonably possible.
- Accepting to participate in the study.
Who cannot join
- Definite rupture of membranes.
- Established preterm labor.
- Severe attack of bleeding requiring an immediate intervention.
- Fetal heart rates instability or non reassuring
- Intrauterine fetal death or major fetal anomalies.
- If associated with abruptio placentae
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- Patients with known bleeding disorders or on anticoagulant therapy
- Patents with severe medical disorders as preeclamptic toxemia, diabetes mellitus, hepato-renal impediment …etc
- The presence of reported side effects in the mother from 17α hydroxy progesterone caproate like hypersensitivity reactions, cough, dyspnea, and diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use Of Intramuscular Hydroxyprogesterone Caproate For Management Of Placenta Previa Before 34 Weeks Of Gestation
Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide.
Placenta previa is a placenta inserted wholly or in part into the lower segment of the uterus. It is classified by ultrasound to Placenta previa major degree when the lower edge of the placenta lies within 2 cm from the internal cervical os and Placenta previa minor degree if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal os. Placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal mortality of 8.1% in the developed world and much more in developing countries.
Read more
Many studies in literature proved the positive correlation between the Placenta previa and preterm uterine contractility and also reported that large proportion of women who have Placenta previa associated with vaginal bleeding will have subclinical uterine contractions before the onset of evident vaginal bleeding.
There are many tocolytic agents may have a role in conservative management of Placenta previa such as magnesium sulfate and β-sympathomimetics .Progesterone is essential for continuation of pregnancy and helps in maintenance of pregnancy . Delaying delivery may reduce the fetal morbidity by helping maturity of vital organs. In 2003 Meis et al. in a large randomized placebo-controlled trial found a significant reduction in recurrent preterm birth before 37 weeks for women who received 17αHP-C versus a control group receiving placebo (36.3% versus 54.9%).
- Conditions
- Preterm Labor
- Being tested
- 17α hydroxy progesterone caproate
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17α hydroxy progesterone caproateDrug
where patients will have a 17α hydroxy progesterone caproate intramuscular injection every week starting from 24 weeks of gestation till completed 37 weeks
| Study group | Role | What they receive |
|---|---|---|
| 17α hydroxy progesterone caproate group | Active comparator | Not described Receives: Drug: 17α hydroxy progesterone caproate |
| No intervention group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of women delivered before 37 weeks
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Apr 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130504
- Sponsor's protocol ID
- IMHC
- Status last verified
- Jun 2018
- First submitted
- 22 Apr 2017
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Of Intramuscular Hydroxyprogesterone Caproate For Management Of Placenta Previa Before 34 Weeks Of Gestation
- ClinicalTrials.gov ID
- NCT03130504
- Acronym / sponsor ID
- IMHC
- Conditions
- Preterm Labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 26 Apr 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.
Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 24+0 weeks of pregnancy and till delivery of the fetus. Antepartum hemorrhage occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide.
Placenta previa is a placenta inserted wholly or in part into the lower segment of the uterus. It is classified by ultrasound to Placenta previa major degree when the lower edge of the placenta lies within 2 cm from the internal cervical os and Placenta previa minor degree if the lower edge of the placenta at lower uterine segment but more than 2 cm from internal os. Placenta previa is responsible for 0.03% of maternal mortality and 8.1% of perinatal mortality of 8.1% in the developed world and much more in developing countries.
Many studies in literature proved the positive correlation between the Placenta previa and preterm uterine contractility and also reported that large proportion of women who have Placenta previa associated with vaginal bleeding will have subclinical uterine contractions before the onset of evident vaginal bleeding.
There are many tocolytic agents may have a role in conservative management of Placenta previa such as magnesium sulfate and β-sympathomimetics .Progesterone is essential for continuation of pregnancy and helps in maintenance of pregnancy . Delaying delivery may reduce the fetal morbidity by helping maturity of vital organs. In 2003 Meis et al. in a large randomized placebo-controlled trial found a significant reduction in recurrent preterm birth before 37 weeks for women who received 17αHP-C versus a control group receiving placebo (36.3% versus 54.9%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 17α hydroxy progesterone caproate group | Active comparator | Drug: 17α hydroxy progesterone caproate |
| No intervention group | No intervention | – |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Estimated gestational age is ranging between 24 weeks and 26 week's gestation
- Singleton pregnancy.
- Placenta previa; either major or minor degrees.
- Placenta previa with minimal vaginal bleeding or haven't any vaginal bleeding.
- For outpatient follow ups, women should be living in a nearby area to make follow-up and early transportation are reasonably possible.
Key exclusion criteria (9 listed)
- Definite rupture of membranes.
- Established preterm labor.
- Severe attack of bleeding requiring an immediate intervention.
- Fetal heart rates instability or non reassuring
- Intrauterine fetal death or major fetal anomalies.
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 |
|---|---|---|
| 17α hydroxy progesterone caproatewhere patients will have a 17α hydroxy progesterone caproate intramuscular injection every week starting from 24 weeks of gestation till completed 37 weeks | Drug | 17α hydroxy progesterone caproate group |
Primary outcome
number of women delivered before 37 weeks
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 17α hydroxy progesterone caproate in people with Preterm Labor, 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 3 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of women delivered before 37 weeks (time frame: 13 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 3 Jul 2018.