Normotensive and Hypertensive Placental Abruptions

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.

Study Overview

• Status: Completed
• Conditions: Abruptio Placentae; Affecting Fetus or Newborn
• Intervention / Treatment: Other: clinical assesment

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 Type: Observational
• Enrollment (Actual): 115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Two groups were formed according to presence or absence of hypertension (53 hypertensive, 62 normotensive) who has placental abruption.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (with hypertension ); Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).	Other: clinical assesment; Comparison of Hypertensive group and normotensive group
Group 2( without hypertension); Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).	Other: clinical assesment; Comparison of Hypertensive group and normotensive group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure measurement	mm Hg	2 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	first 1 hour
maternal and newborn length, weight	centimeters,kilogram	5 minute
APGAR score	1st and 5th minute newborn assesment	5 minute

Collaborators and Investigators

• Sponsor: Hatice Akkaya
• Investigators: Principal Investigator: Hatice Akkaya, Ass Prof, Kayseri Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): April 30, 2017
• Study Completion (ACTUAL): November 30, 2017

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (ACTUAL): June 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: hypertension; mean platelet volume; Abruptio placenta; complete blood count; perinatal outcome.
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Abruptio Placentae
• Other Study ID Numbers: E52332816/49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data belonging to participant only will be available to any researcher or editorial review board if needed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No