Cervical preparation for first trimester surgical abortion.

BACKGROUND: Preparing the cervix prior to surgical abortion is intended to make the procedure both easier and safer. Options for cervical preparation include osmotic dilators and pharmacologic agents. Many formulations and regimens are available, and recommendations from professional organizations vary for the use of preparatory techniques in women of different ages, parity or gestational age of the pregnancy. OBJECTIVES: To determine whether cervical preparation is necessary in the first trimester, and if so, which preparatory agent is preferred. SEARCH STRATEGY: We searched Cochrane, Popline, Embase, Medline and Lilacs databases for randomised controlled trials investigating the use of cervical preparatory techniques prior to first trimester surgical abortion. In addition, we hand-searched key references and contacted authors to locate unpublished studies or studies not identified in the database searches. SELECTION CRITERIA: Randomised controlled trials investigating any pharmacologic or mechanical method of cervical preparation, with the exception of nitric oxide donors (the subject of another Cochrane review), administered prior to first trimester surgical abortion were included. Outcome measures must have included the amount of cervical dilation achieved, the procedure duration or difficulty, side-effects, patient satisfaction or adverse events to be included in this review. DATA COLLECTION AND ANALYSIS: Trials under consideration were evaluated by considering whether inclusion criteria were met as well as methodologic quality. Fifty-one studies were included, resulting in 24 different cervical preparation comparisons. Results are reported as odds ratios (OR) for dichotomous outcomes and weighted mean differences for continuous data. MAIN RESULTS: When compared to placebo, misoprostol (400-600 microg given vaginally or sublingually), gemeprost, mifepristone (200 or 600 mg), prostaglandin E and F(2alpha) (2.5 mg administered intracervically) demonstrated larger cervical preparation effects. When misoprostol was compared to gemeprost, misoprostol was more effective in preparing the cervix and was associated with fewer gastrointestinal side-effects. For vaginal administration, administration 2 hours prior was less effective than administration 3 hours prior to the abortion. Compared to oral misoprostol administration, the vaginal route was associated with significantly greater initial cervical dilation and lower rates of side-effects; however, sublingual administration 2-3 hours prior to the procedure demonstrated cervical effects superior to vaginal administration.When misoprostol (600 microg oral or 800 microg vaginal) was compared to mifepristone (200 mg administered 24 hours prior to procedure), misoprostol had inferior cervical preparatory effects. Compared to day-prior laminaria tents, 200 or 400 microg vaginal misoprostol showed no differences in the need for further mechanical dilation or length of the procedure; similarly, the osmotic dilators Lamicel and Dilapan showed no differences in cervical ripening when compared to gemeprost, although gemeprost had cervical effects which were superior to laminaria tents. Older prostaglandin regimens (sulprostone, prostaglandin E(2) andF(2alpha)) were associated with high rates of gastrointestinal side-effects and unplanned pregnancy expulsions. Few studies reported women's satisfaction with cervical preparatory techniques. AUTHORS' CONCLUSIONS: Modern methods of cervical ripening are generally safe, although efficacy and side-effects between methods vary. Reports of adverse events such as cervical laceration or uterine perforation are uncommon overall in this body of evidence and no published study has investigated whether cervical preparation impacts these rare outcomes. Cervical preparation decreases the length of the abortion procedure; this may become increasingly important with increasing gestational age, as mechanical dilation at later gestational ages takes longer and becomes more difficult. These data do not suggest a gestational age where the benefits of cervical dilation outweigh the side-effects, including pain, that women experience with cervical ripening procedures or the prolongation of the time interval before procedure completion. Mifepristone 200 mg, osmotic dilators and misoprostol, 400microg administered either vaginally or sublingually, are the most effective methods of cervical preparation.

Cervical dilation in second-trimester abortion.

Dilation and evacuation, the most common method performed for second-trimester abortion in the United States, requires sufficient cervical dilation to reduce the risk of complications such as cervical laceration or uterine perforation. The cervix may be prepared with osmotic dilators such as laminaria, Lamicel, or Dilapan-S, or with pharmacologic agents such as misoprostol. Dilapan-S and Lamicel achieve their maximum dilation faster than laminaria, making same-day procedures possible. Misoprostol has limited data supporting its use in this setting. Decisions regarding which method is best are clinician-dependent, and factors such as gestational age and time allowed for preparation should be considered.

Cervical preparation for second-trimester surgical abortion prior to 20 weeks of gestation.

Roughly 11% of induced abortions in the United States are performed after 14 weeks of gestation, most commonly by dilation and evacuation (D&E). For a D&E procedure, the cervix must be dilated sufficiently to allow passage of operative instruments and products of conception without injuring the uterus or cervical canal. Preoperative preparation of the cervix reduces the risk of cervical laceration and uterine perforation. The cervix may be prepared with osmotic dilators, prostaglandin analogues, or both. Osmotic dilators currently available in the United States include Dilapan-S, Lamicel, and laminaria. Laminaria tents are made from dehydrated seaweed and require 12-24 h to achieve greatest dilation. The synthetic products, Dilapan-S and Lamicel, achieve maximum effect within 6 h. Dilapan-S achieves greater dilation than the others and, thus, requires fewer dilators to be placed but may be more difficult to remove. For same day procedures, Dilapan-S and Lamicel are preferable to laminaria. A single set of one to several dilators is usually adequate for D&E before 20 weeks of gestation. Additional sets over 1-2 days may be needed in challenging cases. Misoprostol, a prostaglandin analogue, is sometimes used instead of osmotic dilators; however, the data to support such use are limited. Misoprostol is inferior to overnight dilation with laminaria for cervical priming prior to D&E. Misoprostol use as an adjunct to overnight osmotic dilation is only marginally beneficial for priming beyond 16 weeks and does not truly demonstrate any benefit before 19 weeks of gestation. Limited data demonstrate the safety of misoprostol prior to D&E in patients with a uterine scar. The Society of Family Planning recommends preoperative cervical preparation to decrease the risk of complications when performing a D&E prior to 20 weeks of gestation. The three currently available osmotic dilators (laminaria, Lamicel, and Dilapan-S) are safe and effective for this use. Since no single protocol has been found to be superior, clinical judgment is warranted when selecting a method of preoperative cervical preparation.

A pilot clinical trial of ultrasound-guided postplacental insertion of a levonorgestrel intrauterine device.

BACKGROUND: Postplacental intrauterine device (IUD) insertion is a safe, convenient and effective option for postpartum contraception. Few studies involve ultrasound-guided insertion, and none involve the levonorgestrel IUD or take place in the United States. STUDY DESIGN: The study was conducted to assess the safety and feasibility of ultrasound-guided postplacental insertion of the levonorgestrel IUD following vaginal delivery in a U.S. residency program. Levonorgestrel IUDs were inserted under ultrasound guidance within 10 min of placental delivery by hand or using ring forceps. Subjects were examined at 4 and 10 weeks postpartum for evidence of expulsion or infection. RESULTS: Thirty-four subjects were enrolled and 20 received an IUD. Follow-up data are available for 19 subjects over the 10-week follow-up period; 16 subjects returned for the 4-week follow-up, and 14 returned at 10 weeks. Two additional subjects could be contacted by telephone only. At 4 and 10 weeks postpartum, no subjects had evidence of infection. There were two expulsions (2/19, 10.5%) by 10 weeks postpartum. None of the subjects examined had a partial expulsion (intracervical location of the IUD). CONCLUSIONS: In this pilot study, ultrasound-guided postplacental insertion of the levonorgestrel IUD was feasible and not associated with infection. The risk of expulsion was acceptable. Ultrasound-guided postplacental insertion of the levonorgestrel IUD may be an alternative to delayed insertion but warrants further study.

Oral mifepristone and buccal misoprostol administered simultaneously for abortion: a pilot study.

BACKGROUND: Simultaneous oral mifepristone and vaginal misoprostol has a 24-h expulsion rate of approximately 90% when used for abortion through 63 days' gestation. This pilot study sought to determine if a simultaneous regimen using buccal misoprostol would be similarly effective and merit further investigation. STUDY DESIGN: One hundred twenty women were enrolled into three equal groups by gestational age: < or =49 days (Group 1), 50-56 days (Group 2) and 57-63 days (Group 3). After swallowing 200 mg of mifepristone, subjects received 800 mcg buccal misoprostol. Participants returned in 24+/-1 h for evaluation of expulsion by ultrasonography. Women with a persistent gestational sac received 800 mcg vaginal misoprostol. Further follow-up occurred at 1, 2 and 5 weeks by telephone or in person, as appropriate. Sample sizes for each group were estimated with the aim of establishing a 24-h expulsion rate of 90% (95% CI=76-95). RESULTS: The 24-h expulsion rates for Groups 1, 2 and 3 were 73% (95% CI=56-85), 69% (95% CI=52-83) and 73% (95% CI=56-85), respectively. Common side effects were nausea (62%), vomiting (33%) and diarrhea (48%), which did not differ by gestational age. Forty-three percent of subjects found the taste of buccal misoprostol objectionable; 30% found buccal retention uncomfortable or inconvenient, and 10% reported oral irritation, sensitivity, numbness or oral ulcers. CONCLUSIONS: Simultaneous oral mifepristone and buccal misoprostol had a lower-than-hypothesized expulsion rate at 24 h. Although overall success rates at 7 or 15 days could have been higher than those observed at 24 h, we believe that this regimen does not warrant further study.

Immediate versus delayed insertion of the levonorgestrel-releasing intrauterine device following dilation and evacuation: a randomized controlled trial.

BACKGROUND: The study was conducted to compare 6-month usage of the levonorgestrel-releasing intrauterine device (LNG-IUD) when placed immediately or 3 to 6 weeks after dilation and evacuation (D&E) procedure. STUDY DESIGN: We enrolled women undergoing D&E at 15 to 23 weeks of gestation. After completion of the D&E, subjects without contraindications to immediate IUD insertion were randomized to immediate or delayed (3 to 6 weeks later) LNG-IUD insertion. Subjects in the immediate group had the LNG-IUD placed using ultrasound guidance. All subjects returned at 3 to 6 weeks and 8 to 10 weeks after D&E and were contacted by phone at 6 months. RESULTS: Of the 93 subjects enrolled, 88 were randomized. All 44 subjects (100%) randomized to immediate insertion had successful IUD placement, while only 20 (45.5%) of the 44 subjects randomized to delayed insertion returned for IUD placement, all of which were successful [difference 54.5%, 95% confidence interval (CI) 39.8%-69.3%]. Seventeen (38.6%) participants in each group were lost to follow-up. Of subjects contacted at the 6-month follow-up phone call, 23 of 27 women (85.2%) and 17 of 27 women (62.9%) were utilizing the LNG-IUD in the immediate and delayed groups, respectively (difference 22.2%, 95% CI -0.4% to 44.8%). Intrauterine device expulsion occurred in three subjects (6.8%) and one subject (5.0%) in whom the IUD was placed in the immediate and delayed groups, respectively (p=1.0). No significant adverse events occurred. CONCLUSION: Significantly more participants had the LNG-IUD placed in the immediate insertion group compared with the delayed insertion group. Given the low risk of complications, immediate post-D&E insertion of the LNG-IUD should be offered, especially for populations that may have difficulty returning for follow-up.

Outcomes of medical abortion through 63 days in women with twin gestations.

BACKGROUND: Twin gestation is not considered a contraindication to medical abortion with mifepristone and misoprostol. However, data comparing the efficacy of medical abortion for singleton gestations as compared with multiple gestations are limited. We examined medical abortion outcomes for twin gestations through 63 days. STUDY DESIGN: We performed a secondary analysis of treatment efficacy and side effects using pooled data from two randomized medical abortion trials. All subjects received mifepristone 200 mg orally and misoprostol 800 mcg vaginally. Outcomes in women with singleton and twin gestations were compared. RESULTS: Of 2208 subjects, 24 (1.1%) women had twins. Treatment success was not statistically different for twin and singleton gestations (91% vs. 97%, p=.19). Perceived bleeding and pain were not significantly different between groups. CONCLUSIONS: Treatment success of medical abortion for twins is not significantly different than for singletons, although small differences cannot be excluded due to the limited number of twins.

Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial.

OBJECTIVE: To estimate whether 6-month use of the levonorgestrel-releasing intrauterine device (IUD) would be higher when insertion occurred within 10 minutes of placental delivery compared with 6-8 weeks postpartum. METHODS: We enrolled pregnant women planning vaginal deliveries and desiring a postpartum levonorgestrel-releasing IUD. Patients were randomly assigned when admitted in labor to postplacental or delayed IUD insertion. The women followed up in person at 6-8 weeks and 6 months and were contacted by telephone at 3 months. Women were ineligible for a study IUD postenrollment for intrapartum events including infection, hemorrhage, and cesarean delivery; these women were contacted by phone at 3 and 6 months. Expelled IUDs were replaced per patient preference. RESULTS: Successful IUD placement occurred in 50 of 51 participants (98.0%) and 46 of 51 participants (90.2%) in the postplacental and delayed groups, respectively (P=.2). Expulsion within 6 months occurred in 12 of 50 (24.0%; 95% confidence interval [CI], 13.1-38.2) and two of 46 (4.4%; 95% CI 0.5-14.8) participants, respectively (P=.008). Intrauterine device use at 6 months was 43 of 51 (84.3%; 95% CI 71.4-93.0) and 39 of 51 (76.5%; 95% CI 62.5-87.2), respectively (P=.32). For ineligible patients, only 11 of 41 (26.8%) women were using IUDs at 6 months and two (4.9%) had become pregnant. CONCLUSION: Intrauterine device use 6 months after delivery is similar in women who have postpartum or scheduled delayed IUD placement through a study after replacement of expelled IUDs. Expulsions are significantly higher with postplacental compared with delayed IUD placement. Women asked to follow up with their own health care providers for delayed insertion are significantly less likely to receive an IUD. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00476021. LEVEL OF EVIDENCE: I.

Doxycycline serum levels at the time of dilation and evacuation with two dosing regimens.

BACKGROUND: Doxycycline is commonly used for antibiotic prophylaxis before dilation and evacuation (D&E) but frequently causes nausea and emesis which may affect absorption and effectiveness. Taking doxycycline the night prior to surgery may result in adequate absorption with better tolerance. STUDY DESIGN: We enrolled 40 women into a double-blind randomized comparison of doxycycline 200 mg given 4 h before D&E (Group 1) vs. the night prior to D&E with dinner (Group 2). D&E procedures were scheduled after 11 a.m. and subjects were nil per os on the morning of the procedure. Subjects completed symptom diaries from dilator placement until the D&E. Serum for doxycycline assays was obtained before the D&E. RESULTS: Mean gestational age was 19.4 weeks (range 15.8-22.0 weeks) and did not differ by group. Serum was collected at 3.2 h (range 1.9-4.8 h) and 16.3 h (range 13.8-19.1 h) after ingestion of doxycycline in Groups 1 and 2, respectively. Median serum doxycycline levels (milligrams per liter) were 2.7 and 1.8 for Groups 1 and 2, respectively (p=.04). Emesis was experienced by 50% and 15% of women in Groups 1 and 2, respectively (p=.04). Nausea ratings were worse after doxycycline in the morning compared to doxycycline with dinner and compared to placebo at either time (all p<.01). Emesis following doxycycline consumption was not associated with lower doxycycline levels (p>.2). CONCLUSION: When given with food on the night prior to D&E, doxycycline results in less emesis and nausea, but results in lower serum levels at the time of D&E.

Use of dynamic negative airway pressure (DNAP) to assess sedative-induced upper airway obstruction.

BACKGROUND: Traditional methods of assessing ventilatory effects of sedative agents do not measure their propensity to cause upper airway obstruction (UAO). The primary objective of this study was to develop a method, using dynamic negative airway pressure (DNAP), for replicating UAO during deep sedation. METHODS: A state of deep sedation (defined as an Observer Assessment of Alertness and Sedation score of 3 and a bispectral index < 80) was attained in 10 healthy volunteers, aged 19-41, using midazolam. Volunteers breathed through a chamber connected to a regulated source of negative pressure that was gradually adjusted downward to produce UAO based on maximal inspiratory flow. The study consisted of three phases: A control phase while awake, a study phase during midazolam deep sedation, and a recovery phase after flumazenil administration. RESULTS: During the control phase no subject demonstrated airway obstruction at negative pressures to -30-cm H2O. All subjects exhibited complete UAO during DNAP episodes while sedated. Negative pressures required to cause complete UAO (Pcrit) ranged from -2 to -14 cm H2O. After administration of flumazenil, all subjects attained full consciousness within 5 min and did not demonstrate UAO at negative pressures to -30-cm H2O. CONCLUSIONS: Dynamic Negative Airway Pressure is a useful method for provoking midazolam-induced UAO, and may potentially be used to compare the potential for different sedatives and patient factors to cause UAO. Flumazenil was completely effective in reversing the potential for midazolam to cause UAO.