Clinical trial NCT04548102: Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
Official title: Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk
Pregnancy
Keywords: Fetal Movement
Maternal Outcome
Risk Pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group versus control group
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decreased fetal movement count
timeFrame: 37 weeks gestation
measure: Intrauterine fetal death
timeFrame: 37 weeks gestation
measure: Still birth
timeFrame: Within 24 hoursafter delivery
measure: NICU admission
timeFrame: 10 minutes after delivery
Secondary outcomes:
measure: Pregnancy complications
timeFrame: 37 weeks gestation
measure: Delivery outcome
timeFrame: Immediatly after delivery
Other outcomes:
Locations:
city: Faisal
country: Egypt
facility: Rania Mahmoud Abdel Ghani
state: Giza
Study officials:
affiliation: Faculty of Nursing-Cairo University
name: Rania Mahmoud A Ghani, PhD
role: PRINCIPAL_INVESTIGATOR
References: