Complications after interval postpartum intrauterine device insertion.

BACKGROUND: In the United States, up to 57% of women report resumption of sexual activity by the 6 week postpartum visit. Effective contraception should be addressed and provided at that time, to avoid unintended pregnancies and optimize interpregnancy intervals. Long-acting reversible contraceptives are the most effective forms of reversible contraception and are increasingly popular during the postpartum period. However, timing of postpartum intrauterine device (IUD) placement varies among providers and many delay insertion due to concerns for uterine perforation or expulsion of the IUD. OBJECTIVE: This study aimed to evaluate uterine perforation and expulsion rates with IUD insertion at 4-8 weeks postpartum vs 9-36 weeks postpartum. STUDY DESIGN: We performed a retrospective cohort study using the Kaiser Permanente Southern California electronic medical record from 2010 to 2016. We calculated the proportion of perforations and expulsions with IUD insertion at 4-8 weeks vs 9-36 weeks postpartum. Our primary outcome was the perforation rate. Secondarily, we evaluated the expulsion rate. For our minimum sample size calculation, to detect a difference of 0.5% in the perforation rate, with a baseline perforation rate of 0.5% for the 9-36 week postpartum IUD placement group, 80% power, and 5% alpha error rate, we would need at least 4221 participants per group, 8442 in total. RESULTS: A total of 24,959 patients met inclusion criteria (n=13,180 in the 4-8 week group, n=11,777 in the 9-36 week group). Of 430 patients with a confirmed complication, 157 uterine perforations and 273 IUD expulsions were identified. Perforation rates were significantly higher with placement at 4-8 weeks than at 9-36 weeks (0.78% vs 0.46%; P=.001). After adjusting for race and ethnicity, breastfeeding, IUD type, provider type, parity, most recent delivery, and body mass index, the odds of perforation remained higher with placement at 4-8 weeks than at 9-36 weeks (adjusted odds ratio, 1.92; 95% confidence interval, 1.28-2.89). Our Kaplan-Meier survival curve showed that the risk of uterine perforation remained elevated until approximately 22-23 weeks postpartum. Expulsion rates were similar between the 2 groups (1.02 vs 1.17; P=.52). CONCLUSION: Uterine perforation after interval postpartum IUD insertion is greater at 4-8 weeks than at 9-36 weeks, although perforation rates remain low at <1%. Expulsion rates did not differ between the groups. Because overall rates of uterine perforation are low, women can safely be offered IUDs at any interval beyond 4 weeks with minimal concern for perforation.

Acute complications with same-day versus overnight cervical preparation before dilation and evacuation at 14 to 16 weeks.

OBJECTIVE: Evaluate if same-day cervical preparation is associated with a clinically acceptable complication rate compared with overnight osmotic dilators for dilation and evacuation (D&E). STUDY DESIGN: This retrospective, noninferiority, cohort study compared complication rates for same-day versus overnight cervical preparation with D&E between 14 and 16 weeks gestation. Cervical preparation was achieved with misoprostol, osmotic dilators, or both. Our primary outcome was the acute complication rate, defined as: hemorrhage (≥500 mL); hospitalization or hospital transfer; transfusion; or unplanned procedure occurring within 24 hours of the index procedure. Secondarily we evaluated nonmajor (re-aspiration, suture repair of cervical laceration, uterine tamponade, or emergency department only transfer) and major (transfusion, uterine artery embolization, abdominal surgery, or hospital admission) complications separately. Inverse probability of treatment weighting using the propensity score was used to perform an adjusted analysis, taking into account age, ethnicity, clinic location, insurance, gestational age, gravidity, and prior pregnancy outcomes. RESULTS: We analyzed 1,319 subjects (n = 864 same-day, n = 455 overnight). Same-day cervical preparation patients were more likely to have Medicaid and a prior vaginal delivery. In both unadjusted and adjusted analyses, acute complication rates for same-day were noninferior to overnight preparation (unadjusted 0.93% vs 1.98%, difference of -1.05%, CI: -2.48% to 0.38%; adjusted difference -0.50%, CI: -1.45 to 0.44%). Only one major complication in the same-day group, a cervical laceration resulting in hemorrhage requiring transfusion, occurred in the entire sample. CONCLUSIONS: In this retrospective review, same-day cervical preparation was noninferior to overnight preparation for D&E between 14 and 16 weeks gestation, both with low complication rates. IMPLICATIONS: For early second trimester dilation and evacuation, same-day cervical preparation should be considered a safe alternative to overnight cervical preparation.

Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial.

OBJECTIVE: To investigate whether a 20-mL buffered 1% lidocaine paracervical block decreases pain during intrauterine device (IUD) placement. METHODS: In a randomized, single-blind, placebo-controlled trial, women were assigned to receive either a 20-mL buffered 1% lidocaine paracervical block or no block before IUD placement. The primary outcome was pain with IUD placement measured on a 100-mm visual analog scale. Our sample size had 80% power (α=0.05) to detect a 20-mm difference in visual analog scale scores with a SD of 28 mm. Secondary outcomes included pain with speculum placement, paracervical block administration, tenaculum placement, 5 minutes postprocedure, and overall pain perception. RESULTS: From October 7, 2014, through October 26, 2017, 64 women were enrolled and analyzed (33 in the paracervical block arm, 31 in the no-block arm). There were no differences in baseline demographics between the groups. Women who received the paracervical block reported less pain with IUD placement compared with women who received no block (median visual analog scale score of 33 mm vs 54 mm, P=.002). Pain was significantly less in the intervention group for uterine sounding (30 mm vs 47 mm, P=.005), 5 minutes after placement (12 mm vs 27 mm, P=.005), and overall pain perception (30 mm vs 51 mm, P=.015). Participants who received the paracervical block experienced more pain with block administration compared with placebo (30 mm vs 8 mm, P=.003). There was no perceived pain difference for speculum insertion (10 mm vs 6 mm, P=.447) or tenaculum placement (15 mm vs 10 mm, P=.268). CONCLUSION: A 20-mL buffered 1% lidocaine paracervical block decreases pain with IUD placement (primary outcome), uterine sounding (secondary outcome), and 5 minutes after placement (secondary outcome). Although paracervical block administration can be painful, perception of pain for overall IUD placement procedure is lower compared with no block. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02219308.

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 (α=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.

Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial.

OBJECTIVE: To evaluate intramuscular ketorolac compared with placebo saline injection for pain control with intrauterine device (IUD) placement. METHODS: We conducted a randomized, double-blind, placebo-controlled trial between July 2012 and March 2014. Patients received 30 mg ketorolac or placebo saline intramuscular injection 30 minutes before IUD placement. The primary outcome was pain with IUD placement on a 10-cm visual analog scale. Sample size was calculated to provide 80% power to show a 2.0-cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement. RESULTS: A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, body mass index, and race. There were no differences in median pain scores for IUD placement in the placebo compared with ketorolac groups (5.2 compared with 3.6 cm, P=.99). There was a decrease in median pain scores at 5 minutes (2.2 compared with 0.3 cm, P≤.001) and 15 minutes (1.6 compared with 0.1 cm, P≤.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, eight per arm) had a decrease in pain scores with IUD placement (8.1 compared with 5.4 cm, P=.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement. CONCLUSION: Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; www.clinicaltrials.gov, NCT01664559. LEVEL OF EVIDENCE: I.