High RiskNCT04548102
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
A study testing Fetal movement count in people with High Risk and Pregnancy, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- What is being tested?
- Fetal movement count
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Second gravida
- Singleton
- 28 weeks gestation
- History of pregnancy induced hypertension (PIH)
- History of premature rupture of membrane (PROM)
- History of preterm labor
Show all 10Show fewer
- History of gestational diabetes
- History of antepartum hemorrhage
- History of stillbirth
- History of fetal growth restriction
Who cannot join
- History of psychological problems
- Drugs abuse
- Experience any terrible life events during the past 6 months
- Oligohydramnios
- Multi-fetal pregnancy
- Fetal abnormalities
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Fetal movement count
- Keywords
- Fetal Movement, Maternal Outcome, Risk Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal movement countOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fetal Movement Counting | Experimental | Fetal movement counting Receives: Other: Fetal movement count |
| standard antenatal follow up care | No intervention | Women in the control group received the antenatal hospital standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased fetal movement count
Mothers' self report
Measured: 37 weeks gestation
Intrauterine fetal death
Antenatal follow up and examination
Measured: 37 weeks gestation
Still birth
Deliver died fetus or died within 24hrs. after delivery
Measured: Within 24 hoursafter delivery
NICU admission
Newborn Apgar at fifth minutes less than 6
Measured: 10 minutes after delivery
Secondary outcomes (2)
Pregnancy complications
Any progress in mothers' medical conditions that affect thier pregnancy outcomes
Measured: 37 weeks gestation
Delivery outcome
Mode of delivery and delivery complications
Measured: Immediatly after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start30 Sep 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High RiskStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group versus control group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mahmoud Abdel Ghani, Cairo University
- Investigators
- Rania Mahmoud A Ghani, PhD, Principal investigator, Faculty of Nursing-Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548102
- Sponsor's protocol ID
- 0003381
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04548102
- Acronym / sponsor ID
- 0003381
- Keywords
- Fetal Movement, Maternal Outcome, Risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group versus control group
| Arm | Type | Receives |
|---|---|---|
| Fetal Movement Counting | Experimental | Other: Fetal movement countFetal movement counting |
| standard antenatal follow up care | No intervention | –Women in the control group received the antenatal hospital standard care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Second gravida
- Singleton
- 28 weeks gestation
- History of pregnancy induced hypertension (PIH)
- History of premature rupture of membrane (PROM)
Key exclusion criteria (7 listed)
- History of psychological problems
- Drugs abuse
- Experience any terrible life events during the past 6 months
- Oligohydramnios
- Multi-fetal pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal movement countPregnant 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. | Other | Fetal Movement Counting |
Primary outcome
Decreased fetal movement count
Time frame: 37 weeks gestation
Mothers' self report
Intrauterine fetal death
Time frame: 37 weeks gestation
Antenatal follow up and examination
Still birth
Time frame: Within 24 hoursafter delivery
Deliver died fetus or died within 24hrs. after delivery
NICU admission
Time frame: 10 minutes after delivery
Newborn Apgar at fifth minutes less than 6
2 secondary outcomes
Pregnancy complications
Time frame: 37 weeks gestation
Delivery outcome
Time frame: Immediatly after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Mahmoud A Ghani, PhD principal investigator
Faculty of Nursing-Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal movement count in people with High Risk and Pregnancy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased fetal movement count (time frame: 37 weeks gestation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.