Abortion Clinical Trial
Official title:
Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Therapeutic Abortion - A Randomized Trial
This is a randomized, controlled trial investigating whether immediate versus standard, "Sunday Start", initiation of oral contraceptive pills (OCPs) in post-abortion subjects can improve compliance and the continuation of contraception. Immediate initiation of OCPs has been studied in women seeking contraception when they are not immediately post-abortion, and this "Quick Start" method has been shown to improve the continuation of OCPs into a second pill pack. The primary hypothesis of this study is that immediate initiation of OCPs in post-abortal women will improve the continuation of contraception over delayed initiation on the first Sunday after an abortion.
The United States has a higher rate of unintended pregnancy than Canada or any other
developed nation in Europe. OCPs are the most common method of hormonal contraception used
in this country. Perfect use can lead to failure rates as low as 0.1% per year. Actual
failure rates are much higher, often due to non-compliance with OCP use. Several recent
studies have examined the "Quick Start", or initiation of OCPs in front of the provider
while still at the clinic, regardless of time in the cycle. These studies have shown that
women who swallowed the first OCP in the clinic were more likely to continue the OCP into
the second month. Women who are seen in clinics for a therapeutic abortion (TAB) are often
at extremely high risk for another unintended/unwanted pregnancy. If compliance in OCP use
could be improved in this group of women, unintended/unwanted pregnancy rates could be
reduced. One concern about the "Quick Start" technique is that women may have already
ovulated or conceived when OCPs are initiated mid-cycle. In the post-abortal setting, this
is not a concern. Applying the "Quick Start" technique to post-abortion patients and having
women take the first of their OCPs while still in the clinic after their abortion may
improve compliance and continuation of OCP use.
This is a prospective, randomized, controlled trial in post-abortal women, and will last
approximately 24 months. All of the study subjects will receive a single pack of combination
OCPs and a one-year prescription after their TAB. The women in the immediate start arm will
then take their first OCP in the clinic, observed by clinic staff, before leaving. The
controls will be instructed to begin the OCPs on the first Sunday following their abortion.
All subjects will receive the same medication with the only difference being the timing of
initiation of the OCPs. Measurements of continuation will be determined by telephone
interviews administered at two and six months after the subjects' abortion.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00884403 -
Gestational Age is Underestimated by Menstrual Dating Compared to Ultrasound Dating in Those Undergoing Abortion up to 20 Weeks
|
||
Completed |
NCT02083809 -
Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation
|
N/A | |
Completed |
NCT00986921 -
Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks
|
N/A | |
Completed |
NCT00769912 -
Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia
|
Phase 3 | |
Completed |
NCT06178224 -
Determining Beta-hCG Levels in Patients Through Alternative Sample Types
|
||
Completed |
NCT04181021 -
Evaluation of Values Clarification and Attitude Transformation Workshops on Abortion and Family Planning Service Provision and Client Experience
|
N/A | |
Completed |
NCT01799252 -
Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion
|
N/A | |
Completed |
NCT00795314 -
Propofol-butorphanol Anesthesia During Uterine Curettage
|
Phase 4 | |
Completed |
NCT02580175 -
Surgical Evacuation of Abortion Under Ultrasonographic Guide
|
Phase 2 | |
Enrolling by invitation |
NCT03579550 -
Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus
|
N/A | |
Completed |
NCT01945385 -
Impact of Video Intervention on Postabortal Uptake of Long Acting Reversible Contraception (LARC)
|
N/A | |
Terminated |
NCT01436266 -
Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion
|
Phase 3 | |
Completed |
NCT03227614 -
Friends/Family in the Abortion Procedure Room (FAIR)
|
N/A | |
Recruiting |
NCT03688581 -
What is the Knowledge and Use of Emergency Contraception
|
||
Not yet recruiting |
NCT05471895 -
Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
|
||
Completed |
NCT05688228 -
Voluntary Interruption of Pregnancy on Women's Sexuality
|
||
Completed |
NCT03136068 -
Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation
|
Phase 4 | |
Completed |
NCT04651166 -
Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation
|
Phase 2 | |
Recruiting |
NCT05645614 -
Anxiety and Pain During Intervention for Abortion Under Local Anesthesia
|
||
Completed |
NCT01807715 -
Understanding Women's Contraceptive Expectations at the Time of a First Trimester Surgical Abortion
|