Hysteroscopic Findings in Women Using Progesterone Only Pills (Minipills)
1 other identifier
observational
140
1 country
1
Brief Summary
Hysteroscopic findings in women using progesterone only pills (minipills) :A Prospective cohort study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2021
1 active site
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
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2022
CompletedAugust 27, 2021
August 1, 2021
1 year
August 4, 2021
August 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
primary outcome
Hysteroscopic findings in women using POPs versus those not using hormones.( cervical mucosa , endometrium )
an average of 1 year
Secondary Outcomes (1)
subsidiary
an average of 1 year
Study Arms (2)
study group
women receiving mini pills as a method of contraception with symptoms not diagnosed with us
Control group
women attending to office hysteroscopy unit and not taking hormonal therapy
Interventions
Eligibility Criteria
maternal health and family planning
You may qualify if:
- study group:
- women using POP.
- Age: reproductive age.
- Symptoms: abnormal uterine bleeding without an organic cause.
- Authorization to participate in the study .
- Control group
- women attending to office hysteroscopy clinic
- Age: reproductive Age
- Contraception use : none.
- Hormonal use: none.
- Symptoms: abnormal uterine bleeding without an organic cause. All women in both groups would be subjected to Trans Vaginal U.S before doing hysteroscopy .
You may not qualify if:
- study group
- Coagulopathies
- Any contraindications to POPs as :
- past or current breast cancer, cirrhosis, and use of anticonvulsants
- suspected pregnancy
- current stroke or IHD
- severe hypertension
- Any contraindications to hysteroscopy as :
- Pelvic infection
- Pregnancy
- Cervical cancer
- Heavy uterine bleeding.
- Control group --Women using any type of hormones including COCs .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samuel Gendylead
Study Sites (1)
Women health hospital , Assuit university
Asyut, Assuit, 71515, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Resident of Obstetrics & Gynecology
Study Record Dates
First Submitted
August 4, 2021
First Posted
August 27, 2021
Study Start
September 1, 2021
Primary Completion
September 1, 2022
Study Completion
December 5, 2022
Last Updated
August 27, 2021
Record last verified: 2021-08