NCT02979834

Brief Summary

This study aims to investigate average gestational week in which mothers feel the babies'movements for the first time and maternal-fetal factors affecting this time.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

November 26, 2016

Last Update Submit

November 29, 2016

Conditions

Keywords

fetal movementplacenta sitebody mass indexmaternal education

Outcome Measures

Primary Outcomes (1)

  • placental settlement via ultrasound

    Relationship between placental location obtained via sonography and fetal movement perception

    5 minutes

Secondary Outcomes (8)

  • maternal body mass index measurement

    3 minutes

  • maternal age

    1 minute

  • parity

    1 minute

  • educational status

    1 minute

  • smoking

    1 minute

  • +3 more secondary outcomes

Study Arms (3)

Early perception group

The group with early perception of fetal movement (\<25th percentile)

Average perception group

The group with average perception of fetal movement (\>25th and \<75th percentile)

Late perception group

The group which late perception of fetal movement (\>75 percentile)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Three groups were formed according to the gestational week in which fetal movements felt by mother for the first time. 25th percentile, 50thand 75th percentile values were determined .Participants who felt the babies' movements at or before 25th percentile value constituted Group1 or early perception group, participants who felt the babies' movements between 25th and 75th percentile value constituted Group 2 or average perception group and the participants who felt the babies'movements at or beyond 75th value constituted Group 3 or late perception group. Subsequently, these three groups were compared regarding maternal age, gestational week of inclusion in the study, obstetric features, maternal body mass index values, caffeine consumption, smoking status, maternal education status, placental localization and fetal gender.

You may qualify if:

  • The study population included spontaneous, singleton pregnancies at first and second-trimester of their pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hatice Akkaya, M.D

    Kayseri Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 26, 2016

First Posted

December 2, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 2, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

The data belonging to participant will be available to any researcher or editorial review board if needed.