Unexplained StillbirthEarly Phase 1NCT03601338
Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths
A Early Phase 1 study testing Bemiparin and multivitamins and routine antenatal follow up in people with Unexplained Stillbirth, run by Hawler Medical University at 1 site in Iraq.
Trial summary
Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unexplained Stillbirth
- What is being tested?
- Bemiparin and multivitamins and routine antenatal follow up
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteIraq
- Study dates
- 1 Aug 2015to 6 Dec 2018
- Phase
- Early Phase 1
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Second pregnancy after previous unexplained fetal death
- Singleton pregnancy
- No any medical disorders during pregnancy like diabetes or Systemic Lupus Erythematosus
- Normally located placenta
- No congenital fetal anomalies
- Patient accept to participate
Who cannot join
- Confirmed thrombophilia
- Twin pregnancies
- Refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Second Generation Low Molecular Weight Heparin (Bemiparin) as a Prophylactic for Management of Subsequent Pregnancy After an Unexplained Stillbirth: A Clinical Comparative Study
Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound
Read the detailed description
152 women with history of unexplained stillbirths were identified , umbilical arty Doppler ultrasound was conducted for them at 20-22 weeks gestation . they were divided into two group , group one are those with abnormal resistant index (= or more than 0.6) thy received Bemiparin 2500 IU subcutaneously daily up to 24 hours before delivery .
Group 2 with normal umbilical artery resistant index received no any interventions just routine antenatal follow up .
- Conditions
- Unexplained Stillbirth
- Being tested
- Bemiparin, multivitamins and routine antenatal follow up
- Keywords
- Unexplained stillbirth, Low molecular Weight Heparin, Umbilical artery, Doppler Ultrasound, Antenatal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemiparinDrug
Also called Hibor
second generation low molecular weight Heparin
multivitamins and routine antenatal follow upOther
multivitamins and routine antenatal follow up
| Study group | Role | What they receive |
|---|---|---|
| Bemiparin group | Active comparator | Women with high resistant index of umbilical artery received the intervention Bemiparin Sodium 2,500 IU anti Xa/0.2 ml solution for injection in pre-filled syringe provided for each woman . The injections were received daily since 20 weeks gestation and up to 24 hours before delivery
Other Name: Hibor; Laboratories Rovi pharmaceuticals Receives: Drug: Bemiparin |
| control group | Placebo comparator | Normal umbilical arty resistant index group received only multivitamins and routine antenatal follow up Receives: Other: multivitamins and routine antenatal follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stillbirth
Intrauterine fetal death
Measured: after 20 weeks gestation to the delivery of fetus
Early neonatal death
Death of newborn
Measured: First week of life
Low birth weight
New borne with birth weight less than 5th percentile in kilogram
Measured: first hour of life
Secondary outcomes (3)
Preterm labor
delivery of the fetus before 37 weeks gestation
Measured: 20-37 weeks
Pre-eclampsia
High blood pressure with protein urea
Measured: 20-41 week gestation
major abruptio placenta
Antepartum hemorrhage
Measured: 20-41 week gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2015
- Primary completion1 Dec 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained StillbirthStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pregnant women with history of unexplained fetal death
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahla Alalaf, Hawler Medical University
- Investigators
- shahla k. Alalaf, M.D, Principal investigator, Hawler Medical University, college of Medicine, department of Obstetrics and GynecologyAriana K. Jawad, CABOG, Study director, Kurdistan Board for Medical SpecialistMahabad S. Ali, Diploma, Study chair, Maternity Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601338
- Sponsor's protocol ID
- HawlerMU2.7
- Status last verified
- Dec 2018
- First submitted
- 18 Jul 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Generation Low Molecular Weight Heparin (Bemiparin) as a Prophylactic for Management of Subsequent Pregnancy After an Unexplained Stillbirth: A Clinical Comparative Study
- ClinicalTrials.gov ID
- NCT03601338
- Acronym / sponsor ID
- HawlerMU2.7
- Conditions
- Unexplained Stillbirth
- Keywords
- Unexplained stillbirth, Low molecular Weight Heparin, Umbilical artery, Doppler Ultrasound, Antenatal care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 26 Jul 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.
Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound
Detailed description
152 women with history of unexplained stillbirths were identified , umbilical arty Doppler ultrasound was conducted for them at 20-22 weeks gestation . they were divided into two group , group one are those with abnormal resistant index (= or more than 0.6) thy received Bemiparin 2500 IU subcutaneously daily up to 24 hours before delivery .
Group 2 with normal umbilical artery resistant index received no any interventions just routine antenatal follow up .
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pregnant women with history of unexplained fetal death
| Arm | Type | Receives |
|---|---|---|
| Bemiparin group | Active comparator | Drug: BemiparinWomen with high resistant index of umbilical artery received the intervention Bemiparin Sodium 2,500 IU anti Xa/0.2 ml solution for injection in pre-filled syringe provided for each woman . The injections were received daily since 20 weeks gestation and up to 24 hours before delivery Other Name: Hibor; Laboratories Rovi pharmaceuticals |
| control group | Placebo comparator | Other: multivitamins and routine antenatal follow upNormal umbilical arty resistant index group received only multivitamins and routine antenatal follow up |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Second pregnancy after previous unexplained fetal death
- Singleton pregnancy
- No any medical disorders during pregnancy like diabetes or Systemic Lupus Erythematosus
- Normally located placenta
- No congenital fetal anomalies
Key exclusion criteria (3 listed)
- Confirmed thrombophilia
- Twin pregnancies
- Refused to participate
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 |
|---|---|---|
| BemiparinAlso: Hiborsecond generation low molecular weight Heparin | Drug | Bemiparin group |
| multivitamins and routine antenatal follow upmultivitamins and routine antenatal follow up | Other | control group |
Primary outcome
Stillbirth
Time frame: after 20 weeks gestation to the delivery of fetus
Intrauterine fetal death
Early neonatal death
Time frame: First week of life
Death of newborn
Low birth weight
Time frame: first hour of life
New borne with birth weight less than 5th percentile in kilogram
3 secondary outcomes
Preterm labor
Time frame: 20-37 weeks
Pre-eclampsia
Time frame: 20-41 week gestation
major abruptio placenta
Time frame: 20-41 week gestation
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 10 Dec 2018.
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.
shahla k. Alalaf, M.D principal investigator
Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology
Ariana K. Jawad, CABOG study director
Kurdistan Board for Medical Specialist
Mahabad S. Ali, Diploma study chair
Maternity Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bemiparin and multivitamins and routine antenatal follow up in people with Unexplained Stillbirth, run by Hawler Medical University at 1 site in Iraq.
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 3 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 10 Dec 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 Iraq. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Stillbirth (time frame: after 20 weeks gestation to the delivery of fetus). The study lists 3 primary outcomes in all. 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 10 Dec 2018.