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OpenTrials
Completed

NCT Number: NCT04449601

Normotensive and Hypertensive Placental Abruptions

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.

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Key information

Conditions

Abruptio Placentae; Affecting Fetus or Newborn Abruptio Placentae Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • spontaneous,
  • singleton pregnancies
  • above 25 weeks of gestations with positive fetal cardiac activity

Exclusion criteria

  • 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.

Treatment and study plan

clinical assesment

Other

Comparison of Hypertensive group and normotensive group

Primary outcomes

  1. blood pressure measurement

    Time frame: 2 minute

    mm Hg

Secondary outcomes

  1. hemogram parameters WBC(white blood cell) ,PLT(Platelet), MPV(mean platelet volume), HGB(hemoglobin), Neutrophil lymphocyte ratio..)

    Time frame: first 1 hour

    complete blood test retrospective complete blood count analysis

  2. maternal and newborn length, weight

    Time frame: 5 minute

    centimeters,kilogram

  3. APGAR score

    Time frame: 5 minute

    1st and 5th minute newborn assesment

Sponsors and collaborators

Lead sponsor

Hatice Akkaya

Other Gov

Registry information

Official study title

Comparison of Maternal Neonatal Outcomes of Normotensive and Hypertensive Placental Abruptions: A Novel Approach

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2020
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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