NCT05392660

Brief Summary

There are several physiological advantages for being upright during labour. These include the effect of gravity on the fetus within the uterus; reduced risk of aorto-caval compression this maximizes uterine blood flow to the placenta and fetus during labour and more efficient contractions which lead to shorter first and second stage of labor. In addition, being upright during labour provide better alignment of the fetus; and increased pelvic outlet when the woman is in squatting and kneeling positions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

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

January 2, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

May 19, 2022

Last Update Submit

May 23, 2022

Conditions

Keywords

First stage of laborUpright positionLabor outcomes

Outcome Measures

Primary Outcomes (2)

  • Intensity of labor pain assessed by Visual analogue pain intensity scale

    Assessment of labor pain assessed by VAS (Visual analogue pain intensity scale ).It is a self-reported 10 cm horizontal line which represented the subjective estimation of pain intensity. It comprised 0-10-point numerical scale, No pain (0), Mild pain (\< 4), Moderate pain (4-6), Sever pain (7-10).

    during the procedure

  • duration of first stage of labor

    upright position may decrease the duration of first stage of labor

    during the procedure

Secondary Outcomes (3)

  • duration of second stage of labor

    immediately after intervention

  • fetal outcome

    during the procedure

  • Neonatal outcome

    immediately after intervention

Study Arms (2)

study arm

EXPERIMENTAL

assumed upright position during first stage of labor

Other: assumed upright position during first stage of labor

control arm

NO INTERVENTION

hospital routine care

Interventions

The study group assumed one of upright positions during first stage of labor, defined as walking , sitting, standing, kneeling \& squatting positions )

study arm

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primipara parturient women who admitted to delivery unit;
  • in early active phase of 1st stage of labor (not more than 4cm),
  • age between 20-35 years,
  • had a single, viable, and full term (≥ 37 weeks),
  • with normal fetal heart rate pattern (120-160 b/min),
  • fetus in occipto anterior position
  • free from medical or obstetrical disorders that may interrupt labor progress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of nursing Cairo university

Cairo, 11553, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Allocation of the women to study or control group was carried out through a person not involved in the study nurses in charge during the shift. This allocation was concealed from person allocating a woman into the trial (nurses)
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 26, 2022

Study Start

January 2, 2019

Primary Completion

March 27, 2020

Study Completion

March 27, 2020

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations