Does Postpartum Massage Affect Leptin, Prolactin and Growth HormonePhase 2/3NCT06311643
Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight
A Phase 2/3 study testing Postpartum back massage in study group in people with Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Effect of massage on hormone levels in puerperal women Read more about this study
- Who is it for?
- Ages 25 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone
- What is being tested?
- Postpartum back massage in study group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2023to 1 Mar 2024
- Phase
- Phase 2/3
- 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 25 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- puerperal women within 4 hours of normal delivery and they are primiparous
Who cannot join
- nulliparous More than 30 years or less than 25 years Chronic diseases Caesarean delivery
Trial locations and contacts
1 site in 1 country.
About this study
Effect of massage on hormone levels in puerperal women
Read the detailed description
Postpartum back massage can effectively increase prolactin, growth hormone levels, which in turn can make the baby's growth more healthy and decrease leptin levels, which can protect the child from future obesity and so, clinicians should advise postpartum women to have massage after delivery.
- Being tested
- Postpartum back massage in study group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum back massage in study groupOther
Effleurage massage from shoulders toward lower back
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Postpartum Back Massage is done to puerperal women just after 4 hours of delivery and for 1 month with rate of 3 sessions per week and routine postnatal care Receives: Other: Postpartum back massage in study group |
| Control group | No intervention | Puerperal women just have routine post natal care for 1 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptin and prolactin levels increase
Increase levels of lactating hormones
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start2 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Does Postpartum Massage Affect Leptin, Prolactin and Growth HormoneStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Puerperal woman aged from 25 to 30 years within 4 hours of normal delivery
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Mohammed Torad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311643
- Sponsor's protocol ID
- 35
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information will be releasid on pub med
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ameliorative Potential of Relaxing Back Massage on Puerperial Women's Hormones and Infant Weight
- ClinicalTrials.gov ID
- NCT06311643
- Acronym / sponsor ID
- 35
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 15 Mar 2024 (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.
Effect of massage on hormone levels in puerperal women
Detailed description
Postpartum back massage can effectively increase prolactin, growth hormone levels, which in turn can make the baby's growth more healthy and decrease leptin levels, which can protect the child from future obesity and so, clinicians should advise postpartum women to have massage after delivery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Puerperal woman aged from 25 to 30 years within 4 hours of normal delivery
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Postpartum back massage in study groupPostpartum Back Massage is done to puerperal women just after 4 hours of delivery and for 1 month with rate of 3 sessions per week and routine postnatal care |
| Control group | No intervention | –Puerperal women just have routine post natal care for 1 month |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- puerperal women within 4 hours of normal delivery and they are primiparous
Key exclusion criteria (1 listed)
- nulliparous More than 30 years or less than 25 years Chronic diseases Caesarean delivery
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 |
|---|---|---|
| Postpartum back massage in study groupEffleurage massage from shoulders toward lower back | Other | Study group |
Primary outcome
Leptin and prolactin levels increase
Time frame: 1 month
Increase levels of lactating hormones
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes. Information will be releasid on pub med
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Postpartum back massage in study group in people with Does Postpartum Massage Affect Leptin, Prolactin and Growth Hormone, run by Kafrelsheikh 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Mar 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptin and prolactin levels increase (time frame: 1 month). 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 15 Mar 2024.