Effects of Peri Partum Integrated Nursing Care Versus Routine Care in Placenta Previa : A Randomized Controlled Trail

December 8, 2020 updated by: Professor Atef Darwish, Woman's Health University Hospital, Egypt
At our institution, the annual number of placenta previa was 494 cases (1.7%); of whom 95 cases (19.2%) were proved to have a placenta accreta. Perioperatively, they are subjected to regular care of a tertiary university hospital. This study aims to determine the effectiveness of peri partum integrated nursing care for the patients with placenta previa versus routine care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design:

Experimental design: (randomized control trail)

Setting:

This study will be conducted at Woman's Health Hospital, Assiut University, emergency department and inpatient department.

Sample:

A convenience sample will be used, the total sample will include (100) patients with placenta previa, divided into two group1:1

  • group 1: 50 patients study group
  • group2: 50 patients control group

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Woman's Health University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant Placenta previa

Description

Inclusion Criteria:

  • Pregnant women with diagnosis of placenta previa.

Exclusion Criteria:

  • Other high risk pregnancy cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
peri partum integrated nursing care of placenta previa
  • Part (1) personal data:
  • Part (2) baseline and characteristics of the patients participants:
  • Tool II- An observation checklist: This tool is develop by researcher according to guideline of Royal College of Obstetricians and Gynaecologists, 2018), and divide into three main parts: preoperative, intraoperative and postoperative.
  • Part (1) pre-operative: includes assessment of :
  • patients general condition
  • investigation
  • reserved blood
  • Hemoglobin level
  • Impact of hysterectomy option. -9-

Part (2) Intra-operative:

Includes assessment of :-

  • Investigation
  • Vital signs
  • Hypothermia
  • Blood loss
  • I.V fluid
  • Blood gases
  • Fetal condition and APGAR score.
  • Part (3) Post-operative: Includes:
  • maternal complication
  • fetal complication
  • psychological satisfaction
Procedure: Integrated Nursing care of placenta previa

Phase I :( preparation phase) Phase II: (Implementation phase) includes Preoperative care , intraoperative care and postoperative care by a nurse.

Phase III: (Evaluation phase)
peri partum regular care of placenta previa
Routine nursing care of all cases of placenta previa (preoperative, intraoperative and postoperative)..
Procedure: Integrated Nursing care of placenta previa

Phase I :( preparation phase) Phase II: (Implementation phase) includes Preoperative care , intraoperative care and postoperative care by a nurse.

Phase III: (Evaluation phase)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved maternal and fetal well beings in cases of placenta previa
Time Frame: 2 years
Adding an integrated nursing care to the regular care of cases of placenta previa
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Woman's Health University Hospital, Egypt

Investigators

  • Principal Investigator: Atef Darwish, Woman's Health University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

December 2, 2020

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 15, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

December 10, 2020

Last Update Submitted That Met QC Criteria

December 8, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Randomized controlled trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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