NCT05888896

Brief Summary

the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

June 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

September 21, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

May 25, 2023

Last Update Submit

September 19, 2023

Conditions

Keywords

Foot reflexology - Preeclampsia - Proteinuria

Outcome Measures

Primary Outcomes (1)

  • Mean arterial blood pressure

    the scale that will be used; the Mercury Pressure and Stethoscope; each patient will measured blood pressure before and after treatment

    8 weeks

Secondary Outcomes (3)

  • Overall quality of life questionnaire

    8 weeks

  • Serum cortisol

    8 weeks

  • Proteinuria

    8 weeks

Study Arms (2)

anti-hypertensive drugs

EXPERIMENTAL

Methyldopa tablets 250 mg will be used oral to reduce hypertension

Other: methyldopa tablets 250mg

anti-hypertensive drugs+foot reflexology

EXPERIMENTAL

Methyldopa tablets 250 mg and foot reflexology sessions for 8 weeks ( 30 min 2 times per week) will be used to reduce hypertension

Other: methyldopa tablets 250mg + foot reflexology

Interventions

patients will be taken methyldopa tablets 250mg in the morning orally with a lot of water after breakfast daily and this medication continues for 8 weeks

Also known as: anti-hypertensive drugs
anti-hypertensive drugs

patients will receive methyldopa tablets 250mg in oral way once daily per 8 weeks and patients will receive foot reflexology two sessions per week, every session will last for 30 minutes and sessions will last for 8 weeks.

Also known as: anti-hypertensive drugs+ foot massage
anti-hypertensive drugs+foot reflexology

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant female with preeclampsia
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages were ranged between 20-36 years old.
  • Their body mass index was not exceeding 35 kg/m2.
  • All women were diagnosed as mild preeclampsia.
  • All women were primipara and multipara.

You may not qualify if:

  • Any fractures in foot.
  • Foot ulcer \& infection.
  • Open skin wound in foot.
  • History of stroke.
  • Women less than 20 years and more than 36 years.
  • BMI more than 35 Kg\\m2.
  • Severe preeclampsia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abeer Ali Ahmed Mansour

Asyut, Assuit, 71511, Egypt

RECRUITING

MeSH Terms

Interventions

MethyldopaAntihypertensive Agents

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosineCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Abeer Ali, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double( Participants, outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: anti-hypertensive drugs and foot reflexology
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

June 9, 2023

Primary Completion

August 9, 2023

Study Completion

September 20, 2023

Last Updated

September 21, 2023

Record last verified: 2023-06

Locations