Normotensive and Hypertensive Placental Abruptions

Abruptio Placentae; Affecting Fetus or Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449601
• Other study ID #: E52332816/49
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: June 2020
• Source: Kayseri Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abruptio Placentae
• Abruptio Placentae; Affecting Fetus or Newborn

Intervention

Other:
• clinical assesment
Comparison of Hypertensive group and normotensive group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hatice Akkaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure measurement	mm Hg	2 minute
Secondary	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
Secondary	maternal and newborn length, weight	centimeters,kilogram	5 minute
Secondary	APGAR score	1st and 5th minute newborn assesment	5 minute