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

Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Pregnancy; High Risk
• Intervention / Treatment: Other: Fetal movement count

Detailed Description

The researchers met the pregnant women in antenatal clinics during their routine follow up. Woman who was eligible to be recruited in the study signed the consent after description of the study's purpose. 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. Further, each pregnant woman in the study group was trained how to count the fetal movement (i.e.lying down on her left side after taking her meal, and concentrating on fetal movements, calculate it three times per day, half an hour/ one time and record it in the chart). As a rule, if there are less than 10 movements felt in 2 hours, women should contact her health care provider immediately (Royal college of obstetrician & gynecologists, 2011). Fetal movements counting chart was provided and women telephoned once a week in order to ensure proper recording. They also asked to present the fetal movements' chart to the researcher and thier health care providers in each antenatal follow up visit. Pregnant women in both groups; the study and the control groups followed according to thier antenatal visits schedule till delivery. Women in the control group received the antenatal hospital standard care. The maternal and neonatal outcomes had been assessed at delivery unit.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Faisal, Giza, Egypt, 12944
      • Rania Mahmoud Abdel Ghani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Second gravida
• Singleton
• 28 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fetal Movement Counting; Fetal movement counting	Other: Fetal movement count; 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.
No Intervention: standard antenatal follow up care; Women in the control group received the antenatal hospital standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy complications	Any progress in mothers' medical conditions that affect thier pregnancy outcomes	37 weeks gestation
Delivery outcome	Mode of delivery and delivery complications	Immediatly after delivery

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Rania Mahmoud A Ghani, PhD, Faculty of Nursing-Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Fetal Movement; Maternal Outcome; Risk Pregnancy
• Other Study ID Numbers: 0003381

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