New research indicates that the risk of luteal phase pregnancy following any-cycle-day insertion of contraceptive implants with negative pregnancy testing is low, regardless of menstrual cycle timing, recent contraceptive use, or use of emergency contraception.1
To perform the study, researchers at the University of Colorado assessed a retrospective cohort of young women receiving contraceptive implants at BC4U clinic at the Children’s Hospital Colorado, an adolescent Title X clinic. Patients with negative pregnancy tests were eligible for same-day insertion, regardless of cycle day, contraceptive use, or last intercourse.
To perform the analysis, the researchers computed luteal phase pregnancy rates for those within manufacturer insertion guidelines (defined as five or less days of menstrual onset or seven or less days post-discontinuation of hormonal contraception), as well as those outside the guidelines. For placements outside guidelines, instructions were given to use back-up method for seven days, take a pregnancy test in two to four weeks, and return to the clinic if they suspected they were pregnant.
Scientists reviewed medical records for last menstrual period, current hormonal contraception, emergency contraception provision, and pregnancy tests administered at 12 weeks or less post-implant placement, or later evidence of pregnancy. For patients with positive pregnancy tests or reports, the analysis used standard obstetrical dating (last menstrual period and ultrasound) to determine if conception occurred at two weeks or above of implant placement.
Researchers estimated the occurrence of luteal phase pregnancy when following the manufacturer’s guidelines to be 0.5%. This study was designed to demonstrate no increased incidence of luteal phase pregnancy for insertions outside the manufacturer’s guidelines, with an acceptable risk difference of 0.7%.1
Of 3,180 documented insertions, 1,868 (58.8%) were outside recommended guidelines, the analysis indicated. Women with insertions within guidelines were older (20.2 vs. 19.3 years; P < 0.001) and more likely to be white (40.4% vs. 29.5%; odds ratio [OR], 1.6; 95% confidence interval [CI], 1.4-1.9). Definitive pregnancy data were documented for 1,726 patients: 660 (50.3%) in the within-guidelines group, and 1,066 (57.0%) in the outside guidelines group. Rates of luteal phase pregnancy were 0.3% (2/660; 95% CI, 0.0-1.1%) in the within-guidelines group and 0.9% (10/1,066; 95% CI, 0.5-1.7%) in the outside guidelines group.
“Adopting a protocol of contraceptive implant placement that includes insertion on any cycle day with a negative pregnancy test, and emergency contraception as indicated, does not increase the risk of luteal phase pregnancies, even in a young population with complex reproductive behaviors and challenging historical narratives,” the researchers concluded.
Product labeling for the contraceptive implant states that insertion occur within five days of menses or seven or less days from discontinuation of another hormonal method, and with a negative urine pregnancy test. These guidelines can be challenging to same-day implant initiation for adolescents due to teens’ inconsistent contraceptive use, menstrual cycle irregularities, and problems with accessing appointments during regular clinic hours.
Offering same-day initiation is important in the adolescent and young adult populations because research indicates rates of follow-up may be low, says lead researcher Molly Richards, MD, assistant professor, pediatrics-adolescent medicine, at the University of Colorado School of Medicine.
According to the U.S. Selected Practice Recommendations for Contraceptive Use, providers reasonably can determine if a patient is not pregnant if she exhibits no symptoms or signs of pregnancy and meets any one of the following criteria:
- has not engaged in intercourse since last normal menses;
- has been using a reliable contraception method properly and consistently;
- is within seven days after normal menses;
- is within four weeks postpartum (non-lactating);
- is within the first seven days post-abortion or miscarriage;
- is fully or nearly fully breastfeeding, amenorrheic, and less than six months postpartum.2
This approach can be challenging with adolescents, who are more likely to experience irregular menses, or to be unsure of when their last menses occurred, according to Richards.
“Our study should reassure providers that using this ‘any cycle day’ protocol approach to contraceptive implant insertion in adolescents and young women does not increase the risk of luteal phase pregnancy,” Richards says.
“Overall, this is a useful and important article, and certainly applies to pills, patch, ring, and implants,” says Andrew Kaunitz, MD, University of Florida Research Foundation Professor and associate chairman of the department of obstetrics and gynecology at the University of Florida College of Medicine-Jacksonville. “Given the high stakes with IUDs (e.g., the negative consequences when we place an IUD in a woman later found to be pregnant), however, I am not sure I would be comfortable concluding that this data reassures us that an any-day start approach is appropriate with IUDs.”
According to the Family Planning National Training Center’s Contraceptive Access Change Package, family planning providers should develop systems for same-visit provision of all contraceptive methods. By doing so, providers can make it possible for all patients, including women who choose long-acting reversible contraceptives such as intrauterine devices (IUDs) and implants, to leave their visit with their selected contraceptive method.3
Clinicians should offer women the option to begin birth control at the time of the office visit rather than waiting for her next menses, or returning for another appointment.4 There is no medical reason for providers to routinely require multiple visits to initiate any contraceptive method if the U.S. Selected Practice Recommendations for Contraceptive Use criteria for excluding pregnancy are met.2
Although it has been common practice to require multiple appointments for starting methods such as the IUD or implant, published research and guidance from the CDC and the American College of Obstetricians and Gynecologists indicate that clinicians can initiate and provide the patient’s method of choice in a single visit, unless additional testing is medically indicated.5,6
Same-day initiation of contraception, known as Quick Start, is now an accepted practice among family planners. Almost 90% of respondents to the 2015 Contraceptive Technology Update Contraceptive Survey reported that their facilities offered the program for combined hormonal methods. This statistic compares favorably with the 45% of adolescent health providers who reported Quick Start use in 51 health centers throughout the United States with high rates of teen pregnancy.7
REFERENCES
- Richards M, Teal SB, Sheeder J. Risk of luteal phase pregnancy with any-cycle-day initiation of subdermal contraceptive implants. Contraception 2017;95:364-370.
- Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep 2016;65:1-66.
- Family Planning National Training Center. Contraceptive Access Change Package. Available at: http://bit.ly/2pMjWY8. Accessed May 18, 2017.
- Gavin L, Moskosky S, Carter M, et al; Centers for Disease Control and Prevention (CDC). Providing quality family planning services: Recommendations of CDC and the U.S. Office of Population Affairs. MMWR Recomm Rep 2014;63(RR-04):1-54.
- American College of Obstetricians and Gynecologists (ACOG). Practice bulletin no 121. Long-acting reversible contraception: Implants and intrauterine devices. Obstet Gynecol 2011;118:184-196.
- Bergin A, Tristan S, Terplan M, et al. A missed opportunity for care: Two-visit IUD insertion protocols inhibit placement. Contraception 2012;86:694-697.
- Romero LM, Middleton D, Mueller T, et al. Improving the implementation of evidence-based clinical practices in adolescent reproductive health care services. J Adolesc Health 2015;57:488-495.
New research indicates that the risk of luteal phase pregnancy following any-cycle-day insertion of contraceptive implants with negative pregnancy testing is low, regardless of menstrual cycle timing, recent contraceptive use, or use of emergency contraception.
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