NCT04449601

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

June 20, 2020

Last Update Submit

June 23, 2020

Conditions

Keywords

Abruptio placentacomplete blood counthypertensionperinatal outcome.mean platelet volume

Outcome Measures

Primary Outcomes (1)

  • blood pressure measurement

    mm Hg

    2 minute

Secondary Outcomes (3)

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

    first 1 hour

  • maternal and newborn length, weight

    5 minute

  • APGAR score

    5 minute

Study Arms (2)

Group 1 (with hypertension )

Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).

Other: clinical assesment

Group 2( without hypertension)

Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).

Other: clinical assesment

Interventions

Comparison of Hypertensive group and normotensive group

Group 1 (with hypertension )Group 2( without hypertension)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abruptio PlacentaeHypertension

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hatice Akkaya, Ass Prof

    Kayseri Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 29, 2020

Study Start

January 1, 2016

Primary Completion

April 30, 2017

Study Completion

November 30, 2017

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

The data belonging to participant only will be available to any researcher or editorial review board if needed.