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Completed

NCT Number: NCT04548102

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

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

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rania Mahmoud Abdel Ghani

Faisal, Giza Governorate, 12944, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Decreased fetal movement count

    Time frame: 37 weeks gestation

    Mothers' self report

  2. Intrauterine fetal death

    Time frame: 37 weeks gestation

    Antenatal follow up and examination

  3. Still birth

    Time frame: Within 24 hoursafter delivery

    Deliver died fetus or died within 24hrs. after delivery

  4. NICU admission

    Time frame: 10 minutes after delivery

    Newborn Apgar at fifth minutes less than 6

Secondary outcomes

  1. Pregnancy complications

    Time frame: 37 weeks gestation

    Any progress in mothers' medical conditions that affect thier pregnancy outcomes

  2. Delivery outcome

    Time frame: Immediatly after delivery

    Mode of delivery and delivery complications

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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