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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04548102
Other study ID # 0003381
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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