Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman

NCT04548102 | Completed DMC

• 1 other identifier: 0003381
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Up till now, there is insufficient evidence that daily fetal movement counting for pregnant women who are already have a history of high risk pregnancy is beneficial or not in term of early detection and preventing adverse pregnancy outcomes. Aim The aim of the current study is to evaluate the effect of fetal movement counting on maternal and fetal outcome

Conditions

High Risk; Pregnancy

Keywords

Fetal Movement; Maternal Outcome; Risk Pregnancy

Outcome Measures

Primary Outcomes (4)

• Decreased fetal movement count

  Mothers' self report

  37 weeks gestation

• Intrauterine fetal death

  Antenatal follow up and examination

  37 weeks gestation

• Still birth

  Deliver died fetus or died within 24hrs. after delivery

  Within 24 hoursafter delivery

• NICU admission

  Newborn Apgar at fifth minutes less than 6

  10 minutes after delivery

Secondary Outcomes (2)

• Pregnancy complications

  37 weeks gestation

• Delivery outcome

  Immediatly after delivery

Study Arms (2)

Fetal Movement Counting

EXPERIMENTAL

Fetal movement counting

Other: Fetal movement count

standard antenatal follow up care

NO INTERVENTION

Women in the control group received the antenatal hospital standard care.

Interventions

Fetal movement count OTHER

Pregnant women in the study group received verbal information regarding normal fetal movements (i.e. description of the changing pattern of movement as the fetus develops, normal sleep/wake cycles, and factors which may modify the mother's perception of movements such as maternal weight and placental position), and its importance to be followed during the third trimester. A chart for fetal movements counting provided and to ensure proper performance of this task, women telephoned once a week. They also asked to show the fetal movements chart to the researcher and the health care providers in each visit. Women followed according to her antenatal visits schedule till delivery.

Fetal Movement Counting

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Second gravida
• Singleton
• weeks gestation
• History of pregnancy induced hypertension (PIH)
• History of premature rupture of membrane (PROM)
• History of preterm labor
• History of gestational diabetes
• History of antepartum hemorrhage
• History of stillbirth
• History of fetal growth restriction

You may not qualify if:

• History of psychological problems
• Drugs abuse
• Experience any terrible life events during the past 6 months
• Oligohydramnios
• Multi-fetal pregnancy
• Fetal abnormalities
• Smoking

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Rania Mahmoud Abdel Ghani

Faisal, Giza Governorate, 12944, Egypt

Location

Study Officials

• Rania Mahmoud A Ghani, PhD

  Faculty of Nursing-Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor

Model Details: Intervention group versus control group

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 14, 2020
• Study Start: September 30, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)