NCT04641572

Brief Summary

To encourage the application the recommended positions of the World Health Organization during normal childbirth and its effect on maternal and labor outcomes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 24, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

July 5, 2020

Last Update Submit

November 17, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • The maternal outcome.

    measure labor pain score in each position on pain scale

    Within labor process

  • Newborn outcome

    Measure the APGAR score of the newborn related to each position

    At 1 minute and 5 minutes after delivery.

Secondary Outcomes (2)

  • -Increase self-direction of participants through choosing the preferable position

    Within labor process

  • Improve women's satisfaction of childbirth experience

    After childbirth process.

Study Arms (2)

Supine position

NO INTERVENTION

group A ( control ) will follow the hospital routine positions either supine or lateral during labor

Upright position

EXPERIMENTAL

Group B (intervention) will follow the Standing or walking, Squatting, Sitting, Hands /knees, and Kneeling, positions. Then the researcher will register the time ( minutes/hours) that will be taken and which will be more preferable by the participant.

Other: Choose comfortable position

Interventions

Standing or walking, Squatting, Sitting, Hands /knees, and Kneeling, positions will be taken by the participant during labor.Then the researcher will register the time ( minutes/hours) will be taken and which that will be more preferable by the participant

Also known as: change position
Upright position

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsChildbirth process specific to females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged \> 18 years old with normal pregnancy, primiparas and multi-paras labor cases.

You may not qualify if:

  • All high-risk associated factors (Hypertension- DM, Heart disease- renal disease) will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman Health Hospital

Asyut, 71111, Egypt

RECRUITING

Study Officials

  • Howieda Fouly, PhD

    Woman's Health Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Howieda Fouly, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The researcher will use the simple randomize technique ( lottery withdrawal) to give the participants the right to pick up one of these positions through three letters will be written in three folded papers and put in an envelope, each letter will refer to a certain method. As soon as chosen of the letter the research will apply the chosen method and explain the benefits of that position/ technique for the participant.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Random selection based on the woman's preference for certain positions during her first stage of labor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 5, 2020

First Posted

November 24, 2020

Study Start

June 1, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

November 24, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

The data only will be available for the study co-investigators.

Locations