Clinical trial NCT03398811: Abnormal Uterine Bleeding and Progestin-only Contraceptives
Official title: Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 390
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who requested DMPA, etonogestrel subdermal implant or POPs for pregnancy prevention.

Brief summary: The use of progestin-only methods of contraception has been increased obviously and progressively over the world in the last few years. Progestin-only contraception is an option for women in whom an estrogen-containing contraceptive is either contraindicated or causes additional health concerns.

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.


Eligibility criteria: Inclusion Criteria:

1. Women aged between 18-40 years.
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:

1. Women on any anticoagulant therapy.
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.

Primary outcomes:
measure: Number of women developed vaginal bleeding
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References: