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

NCT04274062 | Completed DMC

• 1 other identifier: Randomized controlled trial
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Placenta Previa Total; Nursing Role

Keywords

placenta previa; Nursing; antepartum hemorrhage; randomized trial

Outcome Measures

Primary Outcomes (1)

• Improved maternal and fetal well beings in cases of placenta previa

  Adding an integrated nursing care to the regular care of cases of placenta previa

  2 years

Study Arms (2)

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

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

Interventions

Integrated Nursing care of placenta previa PROCEDURE

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 integrated nursing care of placenta previa; peri partum regular care of placenta previa

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant Placenta previa

You may qualify if:

• Pregnant women with diagnosis of placenta previa.

You may not qualify if:

• Other high risk pregnancy cases

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Atef Darwish

  Woman's Health University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 18, 2020
• Study Start: May 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 2, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)