Mild Pre-eclampsiaNCT05888896
Effect of Foot Reflexology on Preeclampsia
A study testing methyldopa tablets 250mg and methyldopa tablets 250mg + foot reflexology in people with Mild Pre-eclampsia, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy Read more about this study
- Who is it for?
- Ages 20 to 36 years, women only
- Conditions the study is for
- Mild Pre-eclampsia
- What is being tested?
- methyldopa tablets 250mg and methyldopa tablets 250mg + foot reflexology
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jun 2023to 20 Sep 2023
- 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 20 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Abeer Ali Ahmed Mansour
Asyut, Assuit, 71511
Abeer Ali, Lecturer, 01142602929, abeer_ali96@yahoo.com
About this study
the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy
Read the detailed description
Preeclampsia is defined as arterial hypertension identified for the first time after the 20th week associated with proteinuria. It affects 5% to 7% of all pregnant women. It is more common in primigravida women, women with previous early onset preeclampsia, in age greater than 40 years, previous history of preeclampsia, pre-pregnancy obesity, women who become pregnant with donor eggs, embryo donation and donor insemination. It is responsible for over 70 000 maternal deaths and 500 000 fetal deaths worldwide every year. There are many risk factors for it as: Hypertension, diabetes mellitus, proteinuria, obesity, family history, null parity, multiple pregnancies, use of contraception, older women conception (> 40) and thrombotic vascular disease,edema, renal failure, liver failure and hellp syndrome.Complementary therapies such as massage and foot reflexology are used with patients of preeclampsia, it is to normalize the body's function, break down tension, alleviate stress, improve nerve function and blood supply throughout the body. this trial has two groups; one will receive anti-hypertensive drugs and the second will receive anti-hypertensive drugs+foot reflexology sessions for 8 weeks (30 min, 2 session/ week).
- Conditions
- Mild Pre-eclampsia
- Being tested
- methyldopa tablets 250mg, methyldopa tablets 250mg + foot reflexology
- Keywords
- Foot reflexology - Preeclampsia - Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methyldopa tablets 250mgOther
Also called anti-hypertensive drugs
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
methyldopa tablets 250mg + foot reflexologyOther
Also called anti-hypertensive drugs+ foot massage
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.
| Study group | Role | What they receive |
|---|---|---|
| anti-hypertensive drugs | Experimental | Methyldopa tablets 250 mg will be used oral to reduce hypertension Receives: 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 Receives: Other: methyldopa tablets 250mg + foot reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (3)
Overall quality of life questionnaire
World Health Organization Quality of Life Questionnaire will be used to determine quality of life before and after treatment for all patients
Measured: 8 weeks
Serum cortisol
blood sample will be used to measure level of cortisol before and after treatment
Measured: 8 weeks
Proteinuria
Urine reagent strip devices (dipsticks) will be used to discover it in urine before and after treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start9 Jun 2023
- Primary completion9 Aug 2023
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Pre-eclampsiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- anti-hypertensive drugs and foot reflexology
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ali Ahmed Mansour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888896
- Sponsor's protocol ID
- p.t.REC/012/003568
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Reflexology on Preeclampsia
- ClinicalTrials.gov ID
- NCT05888896
- Acronym / sponsor ID
- p.t.REC/012/003568
- Conditions
- Mild Pre-eclampsia
- Keywords
- Foot reflexology - Preeclampsia - Proteinuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 9 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 5 Jun 2023 (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.
the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy
Detailed description
Preeclampsia is defined as arterial hypertension identified for the first time after the 20th week associated with proteinuria. It affects 5% to 7% of all pregnant women. It is more common in primigravida women, women with previous early onset preeclampsia, in age greater than 40 years, previous history of preeclampsia, pre-pregnancy obesity, women who become pregnant with donor eggs, embryo donation and donor insemination. It is responsible for over 70 000 maternal deaths and 500 000 fetal deaths worldwide every year. There are many risk factors for it as: Hypertension, diabetes mellitus, proteinuria, obesity, family history, null parity, multiple pregnancies, use of contraception, older women conception (> 40) and thrombotic vascular disease,edema, renal failure, liver failure and hellp syndrome.Complementary therapies such as massage and foot reflexology are used with patients of preeclampsia, it is to normalize the body's function, break down tension, alleviate stress, improve nerve function and blood supply throughout the body. this trial has two groups; one will receive anti-hypertensive drugs and the second will receive anti-hypertensive drugs+foot reflexology sessions for 8 weeks (30 min, 2 session/ week).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- anti-hypertensive drugs and foot reflexology
| Arm | Type | Receives |
|---|---|---|
| anti-hypertensive drugs | Experimental | Other: methyldopa tablets 250mgMethyldopa tablets 250 mg will be used oral to reduce hypertension |
| anti-hypertensive drugs+foot reflexology | Experimental | Other: methyldopa tablets 250mg + foot reflexologyMethyldopa tablets 250 mg and foot reflexology sessions for 8 weeks ( 30 min 2 times per week) will be used to reduce hypertension |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| methyldopa tablets 250mgAlso: anti-hypertensive drugspatients 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 | Other | anti-hypertensive drugs |
| methyldopa tablets 250mg + foot reflexologyAlso: anti-hypertensive drugs+ foot massagepatients 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. | Other | anti-hypertensive drugs+foot reflexology |
Primary outcome
Mean arterial blood pressure
Time frame: 8 weeks
the scale that will be used; the Mercury Pressure and Stethoscope; each patient will measured blood pressure before and after treatment
3 secondary outcomes
Overall quality of life questionnaire
Time frame: 8 weeks
Serum cortisol
Time frame: 8 weeks
Proteinuria
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Dipyridamole for Early-Onset Preeclampsia: A Pilot Study of Feasibility, Pharmacokinetics, and Biological Effects
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PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methyldopa tablets 250mg and methyldopa tablets 250mg + foot reflexology in people with Mild Pre-eclampsia, 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 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer Ali, lecturer (01142602929, abeer_ali96@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (time frame: 8 weeks). 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 21 Sep 2023.