Comparative safety and efficacy of a dedicated postpartum IUD inserter versus forceps for immediate postpartum IUD insertion: a randomized trial.
OBJECTIVE: To compare postpartum IUD (PPIUD) insertion using a newly developed dedicated PPIUD inserter (inserter) to insertion with modified Kelly placental forceps (forceps).STUDY DESIGN: We randomized 500 women at five Indian academic centers to PPIUD insertion of a Copper T380A with either the inserter or forceps. The primary outcomes were fundal placement (assessed by post-insertion ultrasound), ease of insertion on a 5-point Likert scale, and safety (infection/perforation). Secondary outcomes included IUD status at 6-8weeks postpartum, assessed by string check, ultrasound, or x-ray.RESULTS: Between September 2015 and July 2016, 480 women completed the study with 20 women excluded due to consent withdrawal (n=4), lost to follow-up (n=10) and protocol deviation (n=6). Median distance from the fundus was similar (p=.36), 5.2 mm (0-130) and 5.8 mm (0-120) in the inserter and forceps groups, respectively. Most providers reported insertion to be easy or very easy with inserter (n=195, 81%) and forceps (n=206, 86%; p=.51). There were no perforations or insertion-related infections. Complete expulsion occurred in 19 (7.9%) in the inserter and 13 (5.4%) forceps groups (p=.28). The inserter group had more partial expulsions (n=26, 10.8% versus n=12, 5.0%,) and self-removals (n=4, 1.7% versus n=0); however, most retained their IUD (174 (72.2%) and 200 (83.7%), respectively) (p=.01). Strings were not visible at follow up in 23 (13.1%) participants in the inserter group and 45 (22.4%) in the forceps group (p=.04).CONCLUSIONS: High fundal placement was similar between groups, with strings subsequently seen more frequently in the inserter group. The inserter's increased partial expulsions and self-removals is likely associated with the longer string.IMPLICATIONS: The easily-performed technique of Cu-T380A PPIUD insertion with the inserter may make immediate PPIUD insertions more convenient for patients and providers. The technique, involving less IUD manipulation and reduced dependence on extra instruments could combine to make PPIUD a more popular option. Since this study has a short follow-up period, further study is needed to better understand comparative outcomes with longer follow-up. Additional research on string management for IUDs inserted with the inserter could help explain the increased number of partial expulsions.
View details for DOI 10.1016/j.contraception.2018.04.019
View details for PubMedID 29750926
Acceptability of a text message-based fertility awareness application for family planning in Lucknow, India.
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics
OBJECTIVE: To assess user satisfaction and acceptability toward a cell phone-based short message system (SMS) application for fertility awareness.METHODS: Between July 1 and September 30, 2013, the present observational study recruited women of reproductive age who were presenting for family planning services in Lucknow, India, who were not pregnant, agreed to use the application, and understood basic English. The application collected information on an individual's menstrual cycle and, using the calendar days approach, predicted fertility. Based on an algorithm, the application sent a daily SMS text indicating the participant's fertility status. Participants completed an acceptability survey at the end of the 60-day pilot period.RESULTS: There were 21 participants enrolled. All reported that the application was highly acceptable, and found it to be private, secure, and convenient. All participants were interested in receiving future SMS reminders for tracking fertility. Most participants (20 [95%]) reported being likely or very likely to recommend the family planning application to friends.CONCLUSION: The application, with the aims of helping participants to identify their most fertile days once a month during ovulation and make informed decisions regarding fertility and contraception, was highly acceptable and might be useful in low-resource settings worldwide. Larger studies are needed for software optimization and determination of long-term effectiveness.
View details for DOI 10.1002/ijgo.12488
View details for PubMedID 29574716
Update on second trimester medical abortion
CURRENT OPINION IN OBSTETRICS & GYNECOLOGY
2017; 29 (6): 413?18
To review recent literature on second trimester abortion with medical methods.Across studies published in the recent past, it is apparent that women prefer shorter procedures and procedure times. Several randomized controlled trials have confirmed adding mifepristone to the second trimester medication abortion regimen results in shorter abortion intervals from first misoprostol administration to complete fetal expulsion. A study of simultaneous administration of mifepristone and misoprostol yielded shorter mean 'total' abortion times, presenting several logistical advantages. Recent studies on the continuous dosing of misoprostol have produced critical evidence to support continued dosing until expulsion. These studies had a more practical design compared with previous protocols that capped the number of misoprostol doses.Second trimester surgical abortion is well tolerated and increasingly expeditious. Further research is needed to refine second trimester medical abortion methods, specific to the mifepristone, misoprostol dosing interval. A 12-hour mifepristone to misoprostol interval may be the optimal interval balancing patient preferences and logistical considerations. Pragmatic dosing, including continuous dosing of misoprostol, could yield results that better inform clinical guidelines and reduce burden on patient, provider, and health facility.
View details for DOI 10.1097/GCO.0000000000000409
View details for Web of Science ID 000415091000008
View details for PubMedID 28922193
Contraceptive counseling in reproductive-aged women treated for breast cancer at a tertiary care institution: a retrospective analysis
2017; 96 (4): 248?53
The objective was to assess the frequency of documented contraceptive and fertility preservation counseling for women treated for breast cancer.We conducted a chart analysis of female breast cancer patients (n=211) ages 18-45 years receiving chemotherapy treatment at Stanford Comprehensive Cancer Center from 2010 to 2014. Primary outcomes of contraceptive counseling and fertility preservation counseling documentation were assessed for frequency. Secondary outcomes included pregnancy testing, contraception use and pregnancy during treatment.Among the total sample (n=211), sexual activity was documented in 24% of patients (n=51). Fifty-one percent (n=108) of patients received pregnancy testing prior to initiation of treatment. Past contraception use was documented in 74% of patients (n=156) and current contraception use in 25% (n=53). Twenty-six percent of patients received fertility preservation counseling alone (n=54), 10% received contraceptive counseling alone (n=22), and 12% received both types of counseling (n=25). Patients were three times more likely to receive contraceptive counseling if using contraception at diagnosis [odds ratio (OR) 3.1, confidence interval (CI) 1.1-9.1, p=.04], and older women were significantly less likely to receive counseling (OR 0.2, CI 0.1-1.0, p=.04). Two patients became pregnant and had an abortion during treatment (1%), and neither patient was using contraception nor received contraceptive or fertility preservation counseling.Documentation of fertility preservation counseling occurs more frequently than contraceptive counseling, but both occur suboptimally. Lack of documentation does not allow us to conclude that counseling did not occur, but it suggests the need to improve documentation and increase awareness of contraceptive needs and counseling.Women undergoing breast cancer treatment do not consistently receive counseling on contraception or fertility preservation as a part of their care. Efforts are needed to ensure that women treated for breast cancer routinely receive counseling about fertility preservation and contraceptive options.
View details for DOI 10.1016/j.contraception.2017.06.004
View details for Web of Science ID 000412793200006
View details for PubMedID 28645785
Update on second-trimester surgical abortion.
Current opinion in obstetrics & gynecology
2016; 28 (6): 510-516
To review the recent literature on surgical second-trimester abortion, with specific attention to cervical preparation techniques.Confirming previous studies, a recent retrospective observational cohort study, including 54?911 abortions, estimated the total abortion-related complication rate to be 0.41% for second-trimester or later procedures. Cervical preparation is known to reduce risks associated with second-trimester dilation and evacuation (D&E). When considering adjuncts to osmotic dilators for cervical preparation prior to D&E after 16 weeks, both misoprostol and mifepristone are effective alone and in combination or as adjuncts to osmotic dilators. Misoprostol consistently has been shown to cause more pain and cramping than placebo, but is an effective adjunct to osmotic dilators after 16 weeks. Although mifepristone has fewer side-effects, at its current price, it may not be as cost-effective as misoprostol.Second-trimester abortion is safe. The use of mifepristone and misoprostol for second-trimester abortion has improved safety and efficacy of medical and surgical methods when used alone or in combination and as adjuncts to osmotic dilators. An important aspect of D&E, cervical preparation, is not a one-size-fits-all practice; the approach and methods are contingent on patient, provider and setting and should consider all the evidence-based options.
View details for PubMedID 27684047
Programmatic experience of post-partum IUD use in Zambia: an observational study on continuation and satisfaction.
The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception
2016; 21 (5): 356-360
The aim of the study was to assess continuation rates and satisfaction among post-partum intrauterine device (PPIUD) accepters.This prospective observational study comprised 591 Zambian women who underwent PPIUD insertion at sites of the Society for Family Health, Lusaka, Zambia. The women were contacted 6-12 months after PPIUD insertion and asked to return to the clinic for interview and examination. If the IUD strings were not visible, an ultrasound was performed. Participants were asked about their satisfaction with the PPIUD. Main outcome measures were short-term PPIUD continuation and reported complications according to time of insertion.Of 591 women enrolled, 305 women attended the follow-up appointment for interview and examination, giving a power of 80% to estimate an expulsion rate of 10?±?5%. The IUD was inserted within 10?min of placental delivery (post-placental insertion) in 24.3% of participants (n?=?74) and within 48?h (immediate post-partum insertion) in 71.1% of participants (n?=?217). The total expulsion rate was 5.6%. Expulsion rates for post-placental and immediate post-partum insertions were 10.8% and 4.1%, respectively. No significant difference in expulsion rates was found (p?=?0.10). Of those with an expulsion, 76.5% (n?=?13) recognised that it had occurred. There were no reported complications, and 94.1% of women reported being satisfied or very satisfied with their PPIUD (n?=?287).Overall, expulsion rates were lower than previously reported, particularly for immediate post-partum insertions. Attention to high fundal placement at insertion is a likely explanation for the low expulsion rates. Contrary to conventional wisdom, these low expulsion rates indicate that previous notions regarding insertion timing may not be accurate. Satisfaction levels were also favourable. PPIUD can be safe, acceptable and feasible in an African setting.
View details for DOI 10.1080/13625187.2016.1201655
View details for PubMedID 27367825
Self-Administered Lidocaine Gel for Pain Control With First-Trimester Surgical Abortion
OBSTETRICS AND GYNECOLOGY
2016; 128 (2): 297-303
To compare pain control at various time points during first-trimester surgical abortion using a patient-administered lidocaine gel compared with a traditional lidocaine paracervical block.We conducted a randomized controlled trial of women undergoing surgical abortion at less than 12 weeks of gestation in an outpatient setting. The primary outcome was pain at cervical dilation as measured on a 100-mm visual analog scale. A sample size of 142 participants was planned to detect a 15-mm or greater difference on the 100-mm visual analog scale with 90% power and a significance level of .025, adding 10% for participant dropout and protocol violations. Participants received either 12 mL of a 1% lidocaine paracervical block or 20 mL of a self-administered, 2% lidocaine gel 20-30 minutes before procedure initiation. Secondary outcomes included anticipated pain, baseline pain, pain with speculum and tenaculum placement, pain after suction aspiration, and pain 30-45 minutes postoperatively.From April to October 2015, a total of 142 women were enrolled (68 in the paracervical block group, 69 in the gel group, and five not analyzed as a result of participant withdrawal). Sociodemographic characteristics were similar between groups. The mean pain score with cervical dilation was 60 mm (95% confidence interval [CI] 54-66) in the paracervical block group and 64 mm (95% CI 59-69) in the gel group (P=.3). There was no significant difference between mean pain scores at any time points measured.Self-administration of lidocaine gel before first-trimester surgical abortion is noninferior to a traditional paracervical lidocaine block and should be considered as an alternative, noninvasive approach to pain control for first-trimester surgical abortion.ClinicalTrials.gov, https://clinicaltrials.gov, NCT02447029.
View details for DOI 10.1097/AOG.0000000000001532
View details for Web of Science ID 000380918500013
A Dedicated Postpartum Intrauterine Device Inserter: Pilot Experience and Proof of Concept.
Global health, science and practice
2016; 4 (1): 132-140
To assess the feasibility, acceptability, and safety of a dedicated postpartum intrauterine device (PPIUD) inserter specifically designed for the post-delivery setting. Primary objectives of fundal placement and expulsion rates were assessed. Secondary objectives were participant satisfaction and IUD retention.In this pilot proof of concept, we enrolled 80 women who presented for PPIUD insertion at 2 government hospitals in Delhi and Lucknow, India, between March and July 2015. PPIUD insertion was completed with the dedicated inserter in all cases, by trained providers with no prior experience in PPIUD insertion, followed immediately by ultrasound to assess location and fundal placement of the IUD. Follow-up took place at 6 to 8 weeks post-insertion, and ultrasound was used to assess IUD location. Providers and participants also completed satisfaction surveys.High fundal placement (?10 mm from uterine fundus) was achieved with the dedicated PPIUD inserter in 82% of cases (n?=?65). There were no perforations or infections among the participants and no other complications associated with use of the dedicated inserter. The mean distance between the IUD and the endometrial verge immediately post-insertion was 5.8 mm (range, 0-31; N?=?80); this distance at follow-up was also 5.8 mm (range, 0-25; n?=?50). Complete expulsion was observed in 6 cases (7.5%), and asymptomatic partial expulsion in 8 cases (10%). Providers reported the majority (93%, n?=?74) of insertions to be easy. The majority (74%, n?=?59) of participants reported the same level of pain before and after insertion.This dedicated PPIUD inserter performed as intended and was found to be safe, with high acceptability among the participants and providers. Further study and use of the dedicated inserter may reveal reduced risk of infection among PPIUD users as well as increased convenience compared with standard PPIUD insertion techniques, and could improve acceptability of postpartum IUD provision among providers. The success of this study has led to the initiation of a formal randomized controlled trial in India to further investigate the acceptability of the dedicated inserter.
View details for DOI 10.9745/GHSP-D-15-00355
View details for PubMedID 27016549
View details for PubMedCentralID PMC4807754