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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548102
• Other study ID #: 0003381
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• High Risk
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Egypt	Rania Mahmoud Abdel Ghani	Faisal	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased fetal movement count	Mothers' self report	37 weeks gestation
Primary	Intrauterine fetal death	Antenatal follow up and examination	37 weeks gestation
Primary	Still birth	Deliver died fetus or died within 24hrs. after delivery	Within 24 hoursafter delivery
Primary	NICU admission	Newborn Apgar at fifth minutes less than 6	10 minutes after delivery
Secondary	Pregnancy complications	Any progress in mothers' medical conditions that affect thier pregnancy outcomes	37 weeks gestation
Secondary	Delivery outcome	Mode of delivery and delivery complications	Immediatly after delivery