Jennifer Fortin

Using Daily Text-Message Reminders to Improve Adherence With Oral Contraceptives: A Randomized Controlled Trial

OBJECTIVE: To estimate whether women receiving daily text-message reminders have increased oral contraceptive pill adherence compared with women not receiving reminders. METHODS: This randomized controlled trial estimated whether there was an effect of daily text-message reminders on oral contraceptive pill adherence of new oral contraceptive pill users. Pill-taking was tracked for 3 months by an electronic monitoring device with wireless data collection. During the study period, participants assigned the intervention received a daily reminder text message. Eighty-two women were assigned randomly to detect a 1.6±2.0 pill difference (90% power, 5% &agr;, 15% dropout). RESULTS: Participants were 79% white, non-Hispanic, 99% high school graduates, and 99% nulliparous with a mean age of 22 years. Most reported condom use with past coital activity, and more than half reported prior emergency contraception use. The mean number of missed pills per cycle did not differ significantly between the groups: 4.9±3.0 for the text-message group and 4.6±3.5 for the control group (P=.60). The number of missed pills per cycle increased over the course of the study, but this pattern did not increase differentially between the groups. Adherence recorded by the electronic monitoring device indicated much poorer adherence than that recorded by patient diaries. Despite poor pill-taking, there were no pregnancies. CONCLUSION: Daily text-message reminders did not improve oral contraceptive pill adherence. Although the lack of benefit may be attributed to the frequent use of alternative reminder systems in the control group, the rate of missed pills when measured objectively was still very high in both groups. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00733707. LEVEL OF EVIDENCE: I

Intracesarean insertion of the Copper T380A versus 6 weeks postcesarean: a randomized clinical trial.

OBJECTIVES To compare rates of Copper T380A intrauterine device (IUD) utilization and satisfaction with immediate versus delayed IUD insertion after cesarean delivery in Kampala, Uganda. METHODS This study was a randomized clinical trial of women undergoing cesarean section who desired an IUD in Kampala, Uganda. Participants were randomly assigned to IUD insertion at the time of cesarean delivery or 6weeks afterward. The primary outcome was IUD utilization at 6months after delivery. RESULTS Among 68 women who underwent randomization, an IUD was inserted in 100% (34/34) of the women in the immediate insertion group and in 53% (18/34) in the delayed group. IUD use at 6 months was higher in the immediate insertion group (93% vs. 50% after delayed insertion; p<.0001). Infection and expulsion were rare and did not differ between groups. When we pooled both groups and looked at IUD users compared to nonusers, 91% (39/43) of IUD users were satisfied or very satisfied with their contraceptive method compared to 44% (11/25) of nonusers (p<.0001). Women who chose not to be in the study or had the IUD removed often did so because of perceived husband or community disapproval. CONCLUSION The 6-month utilization of an IUD after immediate insertion was significantly higher than after delayed insertion without increased complications. Contraceptive satisfaction was significantly higher among IUD users than nonusers. Community and husband attitudes influence IUD utilization and continuation in Kampala, Uganda. IMPLICATIONS This work is important because it shows the safety and efficacy of providing IUDs during cesarean section in a setting where access to any healthcare, including contraception, can be extremely limited outside of childbearing and the consequences of an unintended, closely spaced pregnancy after a cesarean section can be life threatening.

Women's preferences for pain control during first-trimester surgical abortion: a qualitative study

BACKGROUND To explore womens preferences for pain control during first-trimester surgical abortion. STUDY DESIGN Pre- and postoperative semistructured individual interviews were conducted with 40 women divided into eight strata by anesthesia choice, age and prior vaginal delivery status. We identified key themes in the interviews and analyzed baseline characteristics and responses to close-ended questions within and across the strata. RESULTS For most women, pain control options were not the primary concern in choosing a clinic for an abortion. Women who received intravenous (IV) sedation had lower pain scores and were more likely to report that they would recommend that method to a friend than women who received local anesthesia alone. Women described the pain as a cramping, tugging, pulling and scraping sensation. Respondents recommended IV sedation for a woman who was very anxious or could not tolerate pain, even though more nausea and vomiting may occur. CONCLUSIONS Most women felt that pain control decisions should be individualized.

Intramuscular ketorolac versus oral ibuprofen for pain relief in first-trimester surgical abortion: a randomized clinical trial

OBJECTIVE Oral nonsteroidal antiinflammatory medications (NSAIDs) have been shown to reduce pain with first-trimester surgical abortion compared to placebo, but it is unclear if one NSAID is better than another. Some providers administer intramuscular ketorolac, though data regarding its efficacy in abortion are limited. This study was designed to compare oral ibuprofen to intramuscular ketorolac for pain management during first-trimester surgical abortion. STUDY DESIGN This was a randomized, double-blind, controlled trial. Women undergoing first-trimester surgical abortion with local anesthesia were randomized to preprocedural oral ibuprofen, 800 mg given 60-90 min preprocedure, or intramuscular ketorolac, 60 mg given 30-60 min preprocedure. The primary outcome was pain with uterine aspiration on a 21-point, 0-100, numerical rating scale. Secondary outcomes included pain with cervical dilation, postoperative pain and patient satisfaction. RESULTS Ninety-four women were enrolled; 47 were randomized to ibuprofen and 47 to ketorolac. The groups did not differ with regards to demographics, reproductive history or Depression Anxiety Stress Scale scores. Mean pain scores for suction curettage did not differ between groups (52.3 vs. 56.2, p=.53). There was also no difference in pain with cervical dilation (41.6 vs. 45.4, p=0.48) or postoperative pain (22.3 vs. 15.0 p=.076), though patients in the ketorolac group experienced significantly greater arm pain than those who received a placebo injection (30.4 vs. 15.6, p<.001). Satisfaction with pain control did not differ significantly by group. CONCLUSIONS Intramuscular ketorolac does not offer superior pain control compared to oral ibuprofen for first-trimester surgical abortion. IMPLICATIONS Intramuscular ketorolac does not offer superior pain control over oral ibuprofen during first-trimester surgical abortion, is more expensive and causes patients significant arm discomfort. Its use should therefore be reserved for patients who cannot tolerate oral NSAIDs.

Survival impact of tamoxifen use for breast cancer risk reduction: projections from a patient-specific Markov model

The authors estimate tamoxifen’s impact on life expectancy among healthy women. A Markov model compared the effects of 5 years of tamoxifen on survival among 50-year-old postmenopausal women. Scenarios were explored using alternative assumptions with regard to tamoxifen’s long-term effects on breast and endometrial cancer. Postmenopausal women without a uterus had substantial life expectancy gains from tamoxifen (1 to 4 months), whereas women with a uterus had such gains only if they were at a very high breast cancer risk. If tamoxifen’s impact on endometrial cancer persists after treatment is discontinued, women at high risk for endometrial cancer have life expectancy losses from tamoxifen unless they are at a very high risk for breast cancer. The authors conclude that tamoxifen use among postmenopausal women is associated with substantial life expectancy gains. However, this benefit is modulated in women at increased endometrial cancer risk and depends on assumptions concerning tamoxifen’s lingering effects on breast and endometrial cancer.

Medical abortion follow-up with serum human chorionic gonadotropin compared with ultrasonography: a randomized controlled trial.

OBJECTIVE: To estimate whether follow-up with serum human chorionic gonadotropin (hCG) results in fewer unplanned visits and interventions than follow-up with ultrasonography. METHODS: Women were randomized to either in-clinic serum hCG or ultrasound follow-up after medical abortion. The primary outcome, unplanned interventions and visits, was measured as a composite binary outcome including: additional clinic or emergency room visits, repeat dosing of misoprostol, and surgical evacuation of the uterus. Surveys were administered at initial follow-up and again 1 month after abortion to inquire about unscheduled visits, interventions, and patient satisfaction. Medical records were reviewed for evidence of additional interventions and visits. RESULTS: A total of 376 patients was randomized. Most participants were white (56%), single (83%), nulliparous (63%), and had completed high school (96%). Average participant age was 26±6 years and average gestational age was 46±6 days. Within 2 weeks of abortion, there was no significant difference in the rate of unplanned interventions and visits between arms, 8.2% (13/159) in the serum hCG arm compared with 6.6% (10/151) in the ultrasound arm (relative risk 1.23, 95% confidence interval [CI] 0.56–2.73, P=.60). By 4 weeks postabortion, 4.4% (6/135) in the ultrasound arm and 1.4% (2/142) in the hCG arm had undergone surgical evacuation (relative risk 0.32, 95% CI 0.07–1.54, P=.16). The majority in both the serum hCG (88%) and ultrasound (95%) arms was satisfied with their assigned follow-up method. CONCLUSION: Medical abortion follow-up with serum hCG does not reduce the rate of unplanned interventions and visits compared with ultrasonography. Overall, the number of unplanned interventions is low and both methods of follow-up are acceptable to women. CLINICAL TRIAL REGISTRATION: ClincialTrials.gov, www.clinicaltrials.gov, NCT00907725. LEVEL OF EVIDENCE: I

Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether 550 mg oral naproxen sodium given 1 hour before intrauterine device (IUD) insertion is effective for pain relief as compared with placebo. METHODS: This was a randomized, double-blind, placebo-controlled trial. The primary outcome was pain with IUD insertion measured on a 100-mm visual analog scale (VAS). Our sample size was calculated to detect a 15-mm difference in VAS scores with 80% power (&agr;=0.05). Secondary outcomes included pain with tenaculum placement, uterine sounding, and 5 and 15 minutes postinsertion. RESULTS: A total of 118 women were enrolled and analyzed (58 in the naproxen sodium arm, 60 in the placebo arm, 97% nulliparous) between May 11, 2015, and March 25, 2016. There were no differences in baseline demographics or reproductive characteristics between arms. There were no differences in median VAS pain scores for the primary outcome of pain with IUD insertion between the naproxen sodium arm compared with the placebo arm (69 compared with 66 mm, P=.89). There were no differences in the secondary outcomes of median VAS pain scores with tenaculum placement (37 compared with 32 mm, P=.97) or uterine sounding (60 compared with 58 mm, P=.66). However, median pain scores postprocedure were lower in the naproxen arm as compared with the placebo arm: 17 compared with 26 mm (P=.01) at 5 minutes and 13 compared with 24 mm (P=.01) at 15 minutes postinsertion. CONCLUSION: Oral naproxen sodium does not reduce pain with IUD insertion but does reduce pain after insertion and should be considered as a premedication. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02388191.

Early serum human chorionic gonadotropin (hCG) trends after medication abortion.

OBJECTIVES Despite increased reliance on human chorionic gonadotropin (hCG) for early pregnancy monitoring, there is limited information about hCG trends soon after medication abortion. The purpose of this study was to determine if there is a predictable decline in serum hCG values shortly after medication abortion. STUDY DESIGN This is a retrospective study of women with early intrauterine pregnancies who underwent medication abortion with mifepristone and misoprostol and had a serum hCG level on Day 1 (day of mifepristone) and a repeat value on Day 2 to 6. The percent hCG decline was calculated from baseline to repeat measure, with repeat values from the same patient accounted for through repeated measure analysis of variance. RESULTS Eighty-eight women with a mean gestational age of 5.5 weeks and median baseline hCG of 5220 IU met study criteria over a 3-year period. The mean decline (±SD) in hCG from the Day 1 baseline value was 56.9%±29.5% on Day 3, 73.5%±38.6% on Day 4, 86.1%±8.8% on Day 5, and 92.9%±3.4% on Day 6. Eighty-two women (93% of the cohort) had a complete abortion without further intervention. The least square means hCG decline among these women was 57.6% [95% confidence interval (CI): 50.3-64.9%] on Day 3, 78.9% (95% CI: 75.0-82.8%) on Day 4 and 86.2% (95% CI: 81.3-91.1%) on Day 5. CONCLUSION There is a rapid decline in serum hCG within the first few days after early medication abortion. Further research is needed to delineate how soon after medication abortion this decline may be specific enough to confirm abortion completion. IMPLICATIONS This study provides the largest cohort of patients followed with serial hCG values in the first few days after medication abortion. Our findings demonstrate the trend in hCG decline in this population, which may be predictable by Day 5.

Advance notice of contraceptive availability at surgical abortion: a pilot randomised controlled trial

Background With advance notice about the availability and effectiveness of contraceptive methods, abortion patients have more time and information for decision-making. We assessed the impact of an informational telephone call prior to the surgical abortion visit on patient contraceptive knowledge. Methods This was a pilot randomised controlled trial. Prior to their abortion visit, participants were randomised to the intervention message, a standardised notification about the availability, effectiveness and safety of long-acting (LARC) and short-acting reversible contraception (SARC) on the day of the abortion, or to the control message, a reiteration of appointment logistics without information about contraception. At the visit, participants completed a pre-procedure survey to assess contraceptive knowledge and usefulness of the intervention. The primary outcome was knowledge of LARC availability immediately after surgical abortion. A secondary outcome was contraceptive method uptake. Results We enrolled 234 subjects. The pre-visit telephone notification improved knowledge that LARC is available immediately after surgical abortion (71.3% vs 50.9%, P<0.01). Participants in both study arms found the telephone notifications useful. Post-abortion contraceptive method choice did not differ between study arms. Conclusions Advance notice about contraception was acceptable to surgical abortion patients and improved their contraceptive knowledge. Trial registration number NCT02836561.

Serum human chorionic gonadotropin (hCG) trend within the first few days after medical abortion: a prospective study

OBJECTIVES To prospectively describe the decline in serum human chorionic gonadotropin (hCG) in the first 5 days after complete medical abortion and evaluate the influence of initial hCG and gestational duration. STUDY DESIGN We conducted a prospective, physiologic study of women ≤63 days gestation who underwent medical abortion with 200 mg mifepristone and 800 mcg buccal misoprostol. We stratified enrollment into two gestational cohorts, <49 days and 49-63 days, to ensure gestational variability. We collected serum quantitative hCG values on Day 1 (day of mifepristone), Day 3, Day 5 and a routine follow up hCG on Days 7-14. We calculated the percent hCG decline from Day 1 to each repeat measure and evaluated trends based on initial serum hCG level and gestation. RESULTS We enrolled 66 women; 59 were protocol-adherent and included in our analysis. Mean gestation on Day 1 was 49 days and mean baseline hCG was 72,332 IU. Fifty-seven subjects (97%) had a complete medical abortion without further intervention. The mean serum hCG decline among subjects with complete medical abortion was 70.0±10.6% [range 36.9-98.6%] on Day 3 and 91.4±4.4% [range 68.4-97.7%] on Day 5. The mean serum hCG decline from Day 1 to routine follow-up on Days 7-9 was 97.1±1.7% [range 92.4-99.2%], from Day 1 to Day 10-11 was 98.5±1.4% [range 94.7-99.6%] and from Day 1 to Day 12-14 was 98.7±2.8% [range 86.7-99.9%]. There was no difference in percent hCG decline stratified by initial hCG or gestation. CONCLUSIONS There is a rapid and predictable decline in serum hCG as early as Day 5 after complete medical abortion through 63 days gestation. Rate of hCG decline is not affected by initial hCG or gestational duration. IMPLICATIONS For women who require confirmation of complete abortion sooner than 1 week after mifepristone, due to patient preference, logistical constraints or in the setting of pregnancy of unconfirmed location, a single repeat hCG on Day 5 may be clinically useful.