Anne Webb

Estimating the effectiveness of emergency contraceptive pills.

OBJECTIVE We use new estimates of conception probabilities by cycle day of intercourse, where cycle day is measured with day 1 being the first day of bleeding in a cycle, to propose a new approach for estimating the effectiveness of emergency contraceptive pills (ECPs). We use this new approach to examine the absolute effectiveness and the cost-effectiveness of ECPs and whether ECPs are more effective the sooner after unprotected intercourse they are initiated. METHODS Using the new set of conception probabilities, we employ data from two recent clinical trials of ECPs, one from the Population Council and the other from the World Health Organization (WHO), to examine the effectiveness of the combined ECP regimen. RESULTS The expected pregnancy rate among typical users was 6.2% in the Population Council trial and 7.4% in the WHO trial based on conception probabilities by cycle day relative to the day of ovulation. Based on conception probabilities by cycle day relative to the first day of bleeding, the expected pregnancy rates dropped to 5.4% and 5.2%, respectively. The two trials yield conflicting evidence regarding whether effectiveness declines with treatment delay. CONCLUSIONS Our results suggest that the absolute levels of effectiveness for the Yuzpe regimen of emergency contraception and the cost-effectiveness of this regimen have probably been overstated when based on conception probabilities by cycle day relative to day of ovulation.

Experience of IUD/IUS insertions and clinical performance in nulliparous women--a pilot study.

Objectives To assess experience of insertion and use, by nulliparous women, of intrauterine devices (IUDs) and intrauterine systems (IUSs) and the feasibility of a large comparative study. Methods Prospective pilot study of women attending for interval insertion of IUD/IUS or emergency IUD. Problems and experience of the procedure were noted. At three months and one year continuation rates, satisfaction levels and problems were recorded. Case notes were reviewed for non-responders. Results Between May and October 2005, 117 nulliparous women were recruited. Nine had an IUS inserted, and 104 an IUD. Despite a reasonable level of pain at insertion most women gave broadly positive descriptions of the procedure. At one year, 65 women were known to still have their original device. Fifteen had it removed; in six women it was expelled. The satisfaction score was high. There were no pregnancies or perforations. Conclusions Insertion of IUD/IUS was well tolerated by the majority. Continuation and satisfaction rates were high. The IUD/IUS should be offered to nulliparous women as part of the full contraceptive menu. The ease of recruitment in this pilot study suggests that a larger study is feasible.

Modifying the Yuzpe regimen of emergency contraception: a multicenter randomized controlled trial.

OBJECTIVE Emergency contraceptives can prevent unintended pregnancy after unprotected intercourse. The best-studied regimen (“Yuzpe”) consists of ordinary combined oral contraceptives containing levonorgestrel and ethinyl estradiol. Women traditionally take one dose within 72 hours after unprotected intercourse, and a second dose 12 hours later. Historically, half experience nausea and a fifth vomit. The purpose of this study was to determine whether 1) women could use combined oral contraceptives other than those containing levonorgestrel and 2) eliminating the second dose improves comfort and convenience. METHODS Women presenting within 72 hours after unprotected intercourse were randomized to receive 1) standard two-dose Yuzpe, 2) a variant of Yuzpe substituting norethindrone for levonorgestrel, or 3) only the first dose of Yuzpe, followed 12 hours later by a placebo. RESULTS Perfect-use failure rates were low in all groups and did not differ in a statistically significant way (standard Yuzpe 2.0% [n = 589], norethindrone–ethinyl estradiol 2.7% [n = 547], single dose of Yuzpe 2.9% [n = 546]). Typical-use failure rates were slightly higher but similarly did not differ significantly. Side effects were similar across groups, except that women taking the single dose reported half the vomiting. Taking the pills with food did not seem to reduce nausea or vomiting, and the pills were not more effective when started sooner after unprotected intercourse. CONCLUSION Oral contraceptives containing norethindrone–ethinyl estradiol work approximately as well for emergency contraception as levonorgestrel–ethinyl estradiol formulations and should be offered when first-line therapies are not available.

Intrauterine device insertion-related complications: can they be predicted?

Objective To determine risk factors affecting the incidence of intrauterine device (IUD) insertion-related complications and failures and, in particular, whether postcoital IUD insertions have a higher incidence of complications than routine IUD insertions. Design Retrospective case notes analysis. Participants The study examined 545 case notes of patients having IUD insertions at East Cheshire NHS Trust family planning clinics between 1 October 1997 and 31 December 2000. Main outcome measures The incidence of complications at insertion, or up to 12 weeks after insertion, was determined and included failed insertion, cervical problems, syncope, bradycardia, convulsions, early perforation and early expulsion. Fourteen potential risk factors were examined to determine the effect on incidence of complications. Results. Failed insertions were statistically more likely in women who had never previously had a vaginal delivery and also when a less experienced doctor performed the insertion. Nulliparous women were at statistically increased risk of cervical problems and bradycardia. Cervical problems at insertion also increased significantly with age. Patients who were amenorrhoeic at insertion were more likely to suffer an early IUD expulsion. Conclusions Of the potential risk factors, nulliparity was the most important. IUD insertion failures and complications were no more common in postcoital than routine IUD insertions. In general, complications were unpredictable, indicating the need for constant vigilance and the inserting doctor being trained and prepared to deal with any complication arising.

Evidence-guided prescribing of combined oral contraceptives : Consensus statement

There is a need to balance the provision of safe and effective contraception against the desire to avoid interventions which might unnecessarily restrict the availability of combined oral contraceptives (COCs). In March 1996, an international group of recognised authorities in their field met to review the available evidence concerning the effects of COCs and the value of various screening procedures in pre-menopausal women. Current scientific evidence suggests only two pre-requisites for the safe provision of COCs: a careful personal and family medical history with particular attention to cardiovascular risk factors, and an accurate blood pressure measurement. Further assessment is required only if a relevant personal or family history is disclosed or the blood pressure is elevated. Only a small minority of women will require this further assessment.

Expulsions following 1000 GyneFix insertions.

Context The GyneFix intra-uterine device has been used in our family planning service since 1997. One of the perceived advantages is its low expulsion rate, as reported by clinical trials. Objective To calculate expulsion rates in routine clinical use and to look at possible reasons for expulsion. Design Retrospective casenote analysis and opportunistic client consultation. Setting A city centre family planning clinic. Participants The first 1000 GyneFix insertions. Main outcome measures Parity of client, experience of clinician carrying out insertion, time from device insertion to expulsion. Results Overall expulsion rate was 7.6%. There was no significant difference in parity of clients experiencing expulsion. Most (4.7%) expulsions were early, occurring within 3 months of insertion. There was considerable variation in early expulsion rate from one clinician to another. Later expulsions also occurred, up to 28 months after insertion. Increasing experience of the inserting clinician led to lower rates of late expulsion. Unnoticed expulsion led to four unplanned pregnancies. Conclusions The GyneFix expulsion rate in our service is higher than quoted in clinical trials. Early expulsions may be related to insertion technique, representing insufficient implantation of the anchoring knot into the fundal myometrium. Late expulsions also occur, often many months after insertion; the reason for these is unclear. Users should be taught to check for the presence of the thread after each menstrual period and unnoticed expulsion should be confirmed by ultrasound and abdomino-pelvic plain X-ray.

Chlamydia trachomatis screening in young people in Merseyside

Objectives To evaluate the acceptability to young people of proactive Chlamydia trachomatis (CT) information and urine test. To discover the extent of CT infection and the practical implications for completing treatment and partner notification. Design Prospective screening with sexual health questionnaire. Setting Three family planning clinics for young people in Liverpool and South Sefton. Participants Nine hundred and five women and 53 men had urine tests and answered the questionnaire. All aged 20 years or under attending the clinics were given information about CT and safer sex. Main outcome measures The acceptability of proactive information and screening for CT using a urine test. Prevalence of CT infection. The time and effort incurred informing and managing those testing positive. Results The information and urine test were readily accepted. Prevalence of CT was 8.5% in women and 5.7% in men. More than three-quarters of those testing positive were treated, but it took much time and effort, as follow-up attendance was poor. Conclusions The prevalence of CT was high in this population. Young people participated in screening readily. They are interested in this health issue, but it was difficult to hold their attention long enough to complete the process of treatment and contact tracing. Completing this successfully either needs a huge input of resources or a new approach. These results have led to the piloting of an outreach health adviser administering treatment and carrying out partner notification at the screening site. Some of the questions raised by the CMO have been addressed.

Pitfalls of adapting emergency contraception CEU guidance

The introduction of a new oral emergency contraceptive (EC), ulipristal acetate (UPA) with a higher up-front cost, has led many clinicians to consider trying to identify women at higher risk of pregnancy so that they can be preferentially offered the drug that works closer to ovulation. These attempts, however well meaning, are flawed, are not based on the published evidence, go against best practice guidance as established by the Clinical Effectiveness Unit (CEU), and may deprive women at definite risk of pregnancy from making an informed choice. If it were possible to determine, consistently and reasonably accurately, where a woman is in relation to ovulation we could reassure the majority of women that they did not need any EC. We know levonorgestrel …

Why go to Tiger Country? A report of two cases of Implanon® removal

A 33-year-old woman who had used Implanon satisfactorily for 3 years attended for a routine replacement. The insertion had been carried out in the same clinic by an experienced doctor. The patient was slim and the rod was easily palpable over the groove between the biceps and the triceps of the left arm. Under aseptic technique I infiltrated about 1 ml lidocaine 1% just under the distal end of the rod and gently massaged the area with a gauze to allow the anaesthetic to act. The rod was removed with ease by the pop out technique and a further rod was inserted subdermally through the same incision but slightly more medially. Steri-Strips and a bandage were applied. About 10 minutes after leaving the patient returned complaining of numbness and loss of function in her left hand. On examination the left thumb and index finger were warmer than the rest of the hand and their gripping power was reduced. All other movements and sensation in the arm were normal. I explained that her symptoms were probably due to the local anaesthetic effect on a nerve that was close to the previous implant. The effects were compared to dental anaesthesia. I reassured the patient that they would wear off in the next few hours. At follow-up she confirmed that this had indeed happened and that she was happy with her second implant. (excerpt)

Risk of pregnancy and external validity in clinical trials of emergency contraception

Objectives To compare women who enrol in emergency contraception (EC) trials to those who decline and to understand why eligible women decline to participate. Methods Data were collected from all women seeking EC (n = 5787) at three clinics in the USA and UK during a period of nearly 1 year (from September 1997 to August 1998). The main outcome measures were pregnancy risk calculated by adjusted cycle day of ovulation. Results Enrolled and non-enrolled women had similar mean ages and similar mean cycle lengths. However, the enrolled and non-enrolled groups were different with respect to adjusted cycle day of unprotected sexual intercourse (UPSI), the regularity of their cycles, recent hormone use, breastfeeding, the number of other acts of UPSI they had engaged in during the same cycle, and their willingness to participate in the study. Expected pregnancy risk among enrolled patients was higher than among non-enrolled EC seekers (6.5% vs 5.0%, p<0.001, calculated using Dixon conception probabilities, and 5.4% vs 4.6%, p = 0.086, calculated using Trussell conception probabilities). Unwillingness to take part in the study was the most common reason women did not enrol in the trial. Otherwise-eligible women most often declined to enrol because they were concerned about the effectiveness of the trial regimen. Conclusions Women in EC trials are likely to face higher pregnancy risk than the general population. Clinical trials might overestimate the number of pregnancies averted by treatment because the number of expected pregnancies in trial populations is not representative of the population of all EC seekers. This information could be useful in projecting the public health impact of expanded EC access.