Abruptio Placentae; Affecting Fetus or NewbornNCT04449601
Normotensive and Hypertensive Placental Abruptions
An observational study of Abruptio Placentae; Affecting Fetus or Newborn, run by Hatice Akkaya.
Trial summary
Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity and mortality. Most abruptions accept to be related to a chronic placental disease process. Therefore, it is very important to understand these processes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abruptio Placentae; Affecting Fetus or Newborn
- What is being tested?
- clinical assesment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Nov 2017
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: Two groups were formed according to presence or absence of hypertension (53 hypertensive, 62 normotensive) who has placental abruption.
Who may be able to join
- spontaneous,
- singleton pregnancies
- above 25 weeks of gestations with positive fetal cardiac activity
Who cannot join
- multiple gestations,
- presence of fetal or maternal infection,
- chronic inflammatory diseases or connective tissue disorders
- history of myocardial infarction,
- thrombosis
- history of steroid drug usage.
About this study
Official title: Comparison of Maternal Neonatal Outcomes of Normotensive and Hypertensive Placental Abruptions: A Novel Approach
Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity and mortality. Most abruptions accept to be related to a chronic placental disease process. Therefore, it is very important to understand these processes. To analyze maternal and neonatal effects of placental abruption(PA) through a novel classification in the presence of hypertension. Initial hemoglobin parameters were also compared to predict pregnancy outcomes in addition to hypertension.
Read the detailed description
Objective: We aimed to classify placental abruption according to hypertension status.
Methods: This retrospective cohort designed study was conducted on 115 pregnant women with placental abruption. The main parameters scanned and recorded from the hospital database and patient medical files. Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). Maternal demographical and clinical characteristics (abdominal pain, vaginal bleeding) were recorded. APGAR scores below 5 at 1 and 5 min., fetal or neonatal death, admission and length of stay in Neonatal Intensive Care Unit(NICU) were also investigated and compared between the groups.
- Being tested
- clinical assesment
- Keywords
- Abruptio placenta, complete blood count, hypertension, perinatal outcome., mean platelet volume
- Medical subject headings
- Abruptio Placentae, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical assesmentOther
Comparison of Hypertensive group and normotensive group
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (with hypertension ) | Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). Receives: Other: clinical assesment | |
| Group 2( without hypertension) | Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). Receives: Other: clinical assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure measurement
mm Hg
Measured: 2 minute
Secondary outcomes (3)
hemogram parameters WBC(white blood cell) ,PLT(Platelet), MPV(mean platelet volume), HGB(hemoglobin), Neutrophil lymphocyte ratio..)
complete blood test retrospective complete blood count analysis
Measured: first 1 hour
maternal and newborn length, weight
centimeters,kilogram
Measured: 5 minute
APGAR score
1st and 5th minute newborn assesment
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Jan 2016
- Primary completion30 Apr 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abruptio Placentae; Affecting Fetus or NewbornStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Akkaya
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hatice Akkaya, Kayseri Education and Research Hospital
- Investigators
- Hatice Akkaya, Ass Prof, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449601
- Sponsor's protocol ID
- E52332816/49
- Status last verified
- Jun 2020
- First submitted
- 20 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data belonging to participant only will be available to any researcher or editorial review board if needed.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal Neonatal Outcomes of Normotensive and Hypertensive Placental Abruptions: A Novel Approach
- ClinicalTrials.gov ID
- NCT04449601
- Acronym / sponsor ID
- E52332816/49
- Keywords
- Abruptio placenta, complete blood count, hypertension, perinatal outcome., mean platelet volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Hatice AkkayaOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 29 Jun 2020 (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.
Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity and mortality. Most abruptions accept to be related to a chronic placental disease process. Therefore, it is very important to understand these processes. To analyze maternal and neonatal effects of placental abruption(PA) through a novel classification in the presence of hypertension. Initial hemoglobin parameters were also compared to predict pregnancy outcomes in addition to hypertension.
Detailed description
Objective: We aimed to classify placental abruption according to hypertension status.
Methods: This retrospective cohort designed study was conducted on 115 pregnant women with placental abruption. The main parameters scanned and recorded from the hospital database and patient medical files. Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). Maternal demographical and clinical characteristics (abdominal pain, vaginal bleeding) were recorded. APGAR scores below 5 at 1 and 5 min., fetal or neonatal death, admission and length of stay in Neonatal Intensive Care Unit(NICU) were also investigated and compared between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (with hypertension ) | – | Other: clinical assesmentTwo groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). |
| Group 2( without hypertension) | – | Other: clinical assesmentTwo groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Two groups were formed according to presence or absence of hypertension (53 hypertensive, 62 normotensive) who has placental abruption.
Key inclusion criteria (3 listed)
- spontaneous,
- singleton pregnancies
- above 25 weeks of gestations with positive fetal cardiac activity
Key exclusion criteria (6 listed)
- multiple gestations,
- presence of fetal or maternal infection,
- chronic inflammatory diseases or connective tissue disorders
- history of myocardial infarction,
- thrombosis
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 |
|---|---|---|
| clinical assesmentComparison of Hypertensive group and normotensive group | Other | Group 1 (with hypertension ), Group 2( without hypertension) |
Primary outcome
blood pressure measurement
Time frame: 2 minute
mm Hg
3 secondary outcomes
hemogram parameters WBC(white blood cell) ,PLT(Platelet), MPV(mean platelet volume), HGB(hemoglobin), Neutrophil lymphocyte ratio..)
Time frame: first 1 hour
maternal and newborn length, weight
Time frame: 5 minute
APGAR score
Time frame: 5 minute
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 29 Jun 2020.
- Individual participant dataSharing planned: No. The data belonging to participant only will be available to any researcher or editorial review board if needed.
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.
Hatice Akkaya, Ass Prof principal investigator
Kayseri Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Abruptio Placentae; Affecting Fetus or Newborn, run by Hatice Akkaya.
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: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
blood pressure measurement (time frame: 2 minute). 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 29 Jun 2020.