By Rebecca H. Allen, MD, MPH
Associate Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI
Dr. Allen reports she receives grant/research support from Bayer, and is a consultant for Bayer, Mylan, and Merck.
SYNOPSIS: In this retrospective cohort study, the rate of luteal phase pregnancy was 0.4% among 239 women who did not meet pregnancy checklist criteria for intrauterine device insertion.
SOURCE: Castaño PM, Westhoff CL. Experience with same-day placement of the 52 mg levonorgestrel-releasing intrauterine system. Am J Obstet Gynecol 2020; Jan. 13. [Online ahead of print].
This is a retrospective cohort study of all women receiving a 52-mg levonorgestrel intrauterine system (LNG-IUS) at Columbia University from July 2009 to April 2012. Women of any age obtaining the device for contraceptive purposes at gynecologic visits or immediately postabortion were included. Exclusion criteria included women undergoing removal and reinsertion the same day and subsequent replacement for women who had experienced an LNG-IUS expulsion. The insertion was performed after a negative urine pregnancy test. Women also could receive emergency contraception (levonorgestrel 1.5 mg orally) if the provider determined them to be at risk of pregnancy from unprotected intercourse. Data were collected at the time of placement and up to 12 months post-insertion to identify failed placements, perforations, luteal phase pregnancies detected after placement, expulsions, and removals. Subjects were evaluated to identify whether they met any of the following pregnancy checklist criteria to be reasonably sure the patients were not pregnant:
• It has been seven days or less since the start of normal menses for the patient.
• The patient has not had sexual intercourse since the start of the last normal menses.
• The patient has correctly and consistently been using a reliable contraception method.
• It has been seven days or less since spontaneous or induced abortion.
• The patient is within four weeks postpartum.
• The patient is fully or nearly fully breastfeeding (exclusively breastfeeding or the vast majority [≥ 85%] of feeds are breastfeeds), amenorrheic, and less than six months postpartum.1
The authors identified 886 LNG-IUS placements. Of these, 646 women (73%) met at least one pregnancy checklist criterion (33% within seven days after abortion, 30% correctly and consistently using a reliable method of contraception, 13% within seven days of the start of normal menses, 7% had not had intercourse since the beginning of last normal menses, 2% within four weeks postpartum, and 0% fulfilling criteria for lactational amenorrhea), leaving 239 women who did not meet any of the checklist criteria. A total of 14 women (2%) received emergency contraception prior to LNG-IUS insertion. There only was one placement failure because of uterine fibroids. There was one luteal phase pregnancy (0.4%) that occurred in a woman who did not meet checklist criteria, had irregular menstrual cycles, and had unprotected intercourse two days before LNG-IUS placement. She had a negative pregnancy test, and took emergency contraception prior to placement. She was instructed to repeat a pregnancy test and the pregnancy was detected four weeks after placement. She opted to undergo IUS removal and termination of the pregnancy. There were 28 expulsions, 78 removals, and no perforations identified in the 12 months following insertion, with a 74% rate of at least one follow-up encounter documented in the electronic medical record.
According to the Centers for Disease Control and Prevention (CDC), a healthcare provider can be reasonably certain that a woman is not pregnant if she has no symptoms or signs of pregnancy and meets any one of the pregnancy checklist criteria.1 The goal of this checklist is to be reasonably sure a patient is not pregnant, so that contraception can be initiated.
According to the CDC, for methods other than intrauterine devices (IUDs), even if the provider is uncertain about pregnancy status, the benefits of starting a contraceptive likely outweigh the risks since hormonal contraceptives do not cause birth defects.1 Before initiating contraception, the provider also can consider checking a urine pregnancy test in certain situations, as well as offering emergency contraception if the patient has had unprotected intercourse in the past five days. Usually, this “quick-start” protocol requires a follow-up pregnancy test in two to four weeks. However, with IUDs there is a concern that a higher risk exists for ectopic pregnancy, spontaneous abortion, septic abortion, preterm delivery, and chorioamnionitis if the IUD is placed when the patient may have a luteal phase pregnancy or early pregnancy. Therefore, the CDC recommends that the provider be reasonably sure that the individual is not pregnant before inserting an IUD.
The authors of this study wanted to evaluate the utility of this pregnancy checklist in a population of patients seeking same-day LNG-IUS insertion. In their practice, a routine urine pregnancy test was performed prior to IUD insertion. Their hypothesis was that the pregnancy checklist was too restrictive and would exclude patients from accessing same-day LNG-IUS insertion.2 The advantages of same-day LNG-IUS insertion include patient convenience and decreased risk of pregnancy while waiting to come back for another IUD insertion appointment, although bridging contraception could be prescribed. The authors found that a good proportion of patients failed to meet at least one of the pregnancy checklist criteria. These patients had a negative urine pregnancy test and were offered LNG-IUS insertion anyway (with emergency contraception if indicated) and were counseled that they may have a small risk of a luteal phase pregnancy and should repeat a pregnancy test in two to four weeks. Only one woman (0.4%) was found to have a luteal phase pregnancy.
Although these data are reassuring, there are some limitations in that there was no follow-up information for 26% of the sample. In addition, there was no information on the number of women who may have been steered toward using a copper IUD for both emergency and ongoing contraception. Finally, this study protocol requires universal urine pregnancy testing on the day of IUD insertion. Nevertheless, the authors thought their practice style was justified. I would agree, as long as there is shared decision-making with the patient. Patients should be thoroughly counseled on the potential, small risk of an undetected luteal phase pregnancy and the consequences to that pregnancy if an IUD is placed. Some women may not want to take that risk, depending on their values. The authors are to be commended for researching this issue and adding evidence to the literature. It is possible that in the subsequent update to the CDC’s Selected Practice Recommendations for Contraceptive Use, changes to the pregnancy checklist requirement will be made.
- Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep 2016;65:1-66.
- Morroni C, Findley M, Westhoff C. Does using the “pregnancy checklist” delay safe initiation of contraception? Contraception 2017;95:331-334.