Abnormal Uterine Bleeding and Progestin-only Contraceptives
NCT ID: NCT03398811
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
390 participants
OBSERVATIONAL
2018-08-01
2020-11-01
Brief Summary
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Progestogen-only pills are contraceptive pills that contain only synthetic progestogens (progestins) and do not contain estrogen . The progestin-only pill is recommended over regular birth control pills for women who are breastfeeding because the mini-pill does not affect milk production.
The most common progestin-only method used is the injectable depot medroxy-progesterone acetate which had been approved by Food and Drug Administration since 1992 . depot medroxy-progesterone acetate provides reliable, private, long-acting (three months) and reversible contraception. Users of depot medroxy-progesterone acetate don't need daily taking as well as it doesn't affect the intercourse by any mean.
The etonogestrel implant (Implanon) is a single-rod progestin contraceptive method placed subdermally in the inner aspect of upper non dependant arm for three years. Much evidence supports the safety, efficacy, reversibility and acceptability of this contraceptive method.
A common reason women choose to discontinue progestin-only contraception is dissatisfaction with its effects on uterine bleeding which occurs in a significant number of users. Information revealed from many clinical trials shows that abnormal uterine bleeding with progestin-only contraception ranging from 10 to 25 % at first year of use.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Group I "the depot medroxy-progesterone acetate group"
where they will use Depot Medroxyprogesterone Acetate 150 mg injection every 3 month,
Depot medroxy-progesterone acetate
Injection every 3 months
Group II "Implanon group"
where they will have Implanon (etonogestrel implant) 68 mg implant
Etonogestrel
68 mg implant
group III (cerazette group)
where they are using Cerazette pills (desogestrel 75 µg l) one pill every day for 28 days without pill-free interval.
Desogestrel 75 µg
one pill every day for 28 days without pill-free interval.
Interventions
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Depot medroxy-progesterone acetate
Injection every 3 months
Etonogestrel
68 mg implant
Desogestrel 75 µg
one pill every day for 28 days without pill-free interval.
Eligibility Criteria
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Inclusion Criteria
2. Women with more than 12 month postpartum.
3. Women who had normal menstrual pattern (cycle from 21 - 35 days with a same cycle length variation of no more than 5 days, bleeding days from 2-7 days and number of sanitary pads not more than 3 pads without blood clots or flooding of blood).
4. Women wanted to use DMPA, etonogestrel subdermal implant or POPs only for pregnancy prevention for at least 1 year.
Exclusion Criteria
2. Women who had a history of uterine, cervical or ovarian pathology.
3. Women who had uterine bleeding disturbance (including amenorrhea) before recruitment.
4. Women received DMPA injection within the previous 9 months except they had three spontaneous regular menstrual cycles.
5. Severely anemic women (hemoglobin \< 8gm/dl).
6. Women with any contraindications for POCs following the WHO eligibility (Altshuler AL et al., 2015).
7. Women refused to participate in the study.
18 Years
40 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohammed Khairy Ali
Lecturer
Locations
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Women Health Hospital - Assiut university
Asyut, , Egypt
Countries
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Other Identifiers
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POCU
Identifier Type: -
Identifier Source: org_study_id