Tag: morning-after pill

International journal of fertility, 1991

Abstract

Well over 100,000,000 women have used the combined oral contraceptive (OC) pill. As a result of the population explosion in the 1970s and 1980s, there will be almost one third more women in fertile age in the year 2000 than in 1991. In the developing world outside China, the total number of contraceptive users could double in roughly 10 years. China, the total number of contraceptive users could double in roughly 10 years. The pill has a low failure rate, but one study in Egypt found that 90% of women made errors in moving from one packet to the next. Similarly, a 60% error rate was found among users in Colombia.

The vaginal ring delivers combined progestogen and estrogen through a silastic wall. The device can be left in place for 21 days out of 28, and such delivery would virtually eliminate the low risk of hepatocellular carcinoma among OC users. A vaginal progestogen ring is being tested. Over 700,000 women have used Norplant, the subdermal implant method with an effectiveness rate of 99%.

Depo-provera and norethindrone enanthate injections last 2 to 3 months. The Progestasert IUD, containing 38 mg progesterone released at a rate of 65 mcg per day, is effective.

Progesterone-releasing IUDs lasting from 3 to 5 years could complement subdermal implants.

Ethinyl estradiol (205 mg) and diethylstilbestrol (25-50 mg) have both been used as postcoital agents taken within 36 hours for 5 consecutive days after unprotected intercourse. In more than 3000 cases there were 17 pregnancies (.05%). These regimens are replaced by giving combined oral contraceptive tables (e.g., .25 mg d-norgestrel and 50 mg ethinyl estradiol), taken 2 at a time and repeated 12 hours later, within 72 hours of unprotected intercourse. Epidemiological studies have confirmed that the use of the combined oral contraceptive for 3 to 5 years halves a woman’s risk of ovarian or endometrial cancer, and the protection persists for 10 to 18 years after cessation of use.

Sources

• The future of hormonal contraception, International journal of fertility, NCBI PubMed PMID: 1687405, 1991.
• Image credit Alec Favale.

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.

High-dose Diethylstilbestrol DES usage as a post-ovulatory pill

1990 Abstract

It has been known since the 1920s that high-dose oestrogens will prevent implantation and interrupt pregnancy in lower mammals. Following successful use in monkeys, Morris began conducting clinical trials in Yale in the 1960s. The first 100 cases were reported in 1967 (Morris and van Wagenen, 1967)] In these trials 25-50 mg stilboestrol (diethylstilbestrol USP) or 0.5-2.0 mg ethinyloestradiol were administered for five days to a group of carefully observed women with mid-cycle exposure to intercourse and both the presence of sperm in the vagina and a rise in basal body temperature confirmed; no pregnancies occurred.

To be effective, oestrogens must be administered within 72 hours of coitus since they work mainly by interfering with implantation. The exact mechanism remains to be established, but Haspels (1976) reported retarded hyperplasia in endometrial biopsies taken from women given high-dose oestrogens post-coitally, while Board (1970) reported a fall in endometrial carbonic anhydrase concentrations after post-coital oestrogens. There is also some evidence that ovum transport may be affected by high-dose oestrogens in some animal species (Smythe and Underwood, 1975), although there is no evidence for such an effect in humans. These findings have been used to explain the increased incidence of ectopic pregnancy apparent in some studies. Stilboestrol 25-50 mg, ethinyloestradiol 2-5 mg (normally 5 rag) and conjugated oestrogens 30 mg have all been used. All are administered for five days and must be given within 72 hours of intercourse.

The overall mean failure rate of all types of high-dose oestrogen is 0.7% (Fasoli et al, 1989). In 1973, Morris and van Wagenen reported 29 pregnancies in over 9000 mid-cycle exposures, only three of which were attributed to a true method failure. Van Santen and Haspels (1985) reported two pregnancies in 226 women in whom they calculated an expected rate of 11.9 pregnancies.

One case of acute pulmonary oedema during stilboestrol administration (Morris and van Wagenen, 1973) has been reported. Because of the possible association between the thromboembolic disorders and high-dose oestrogens, women with a history of thromboembolism are advised to avoid this form of PCC; however, no directly related incidents have been reported.

It is known that stilboestrol use during pregnancy is associated with an increased risk of vaginal adenosis and clear-cell carcinoma of the vagina and cervix in female offspring. There is no evidence that post-coital use of stilboestrol is associated with such an increased risk. Nevertheless, most clinicians now avoid using stilboestrol under any circumstances.

The common side-effects are those commonly associated with oestrogens. Most studies report nausea in around 50% of patients, mainly on day 1 of administration, and vomiting in up to 25%. These symptoms limit compliance and, if vomiting occurs, reduce efficacy. Up to 23% of women complain of breast tenderness and 11% of both menorrhagia and alteration in the timing of the next menstrual period. Vaginal spotting may occur during or shortly after treatment.

Morris and van Wagenen (1973) reported an increased incidence of ectopic pregnancy following high-dose oestrogens administered postcoitally. Three out of the 29 pregnancies that occurred were ectopic, a highly significant increase in the expected rate. For this reason a previous history of ectopic pregnancy is generally regarded as a contraindication to oestrogen-containing PCCs.

Sources

• Post-ovulatory contraception, Bailliere’s clinical obstetrics and gynaecology, PMID: 2225600, 1990 Jun.
• Image credit Maddie Photography.

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.

Must a Catholic hospital inform a rape victim of the availability of the “morning-after pill” ?

Abstract

The California Court of Appeals discussed in Brownfield v. Daniel Freeman Memorial Hospital, 256 Cal. Rptr. (1989), whether a health-care giver must inform a patient of medical options that the care-giver morally opposes.

In this case, workers in a Catholic hospital refused to inform a rape victim about the “morning-after pill” (diethylstilbestrol) despite the victim’s mother requesting the information, the possibility of a pregnancy, and the need for treatment within 72 hours, because such information conflicted with the institutions’ religious beliefs.

The plaintiff did not become pregnant, and the court dismissed the case because there was no compensable injury; the plaintiff did not appeal the dismissal. The court agreed with the plaintiff that the “morning-after pill” is postcoital contraception (like the IUD), not an abortifacient, since the fertilized ovum has not yet become implanted in the uterine mucosa (nidation).

In reviewing the California Therapeutic Abortion Act the court said that while religious facilities need not perform abortions, the statute does not apply to medical emergencies or spontaneous abortions. The court stated that a patient has the right to self-determination in his or her treatment, superseding the moral and religious convictions of the hospital, and that medical malpractice would exist in cases where “damages have proximately resulted from the failure to provide [a patient] with information concerning…treatment option[s],” when “a skilled practitioner of good standing would have provided her with information…under similar circumstances,” and “that if such information had been provided to her, she would have elected such treatment.”

The court found no duty to provide non emergency treatment, only a duty to inform the patient about treatment options.

Sources

• Must a Catholic hospital inform a rape victim of the availability of the “morning-after pill”?, American journal of hospital pharmacy, NCBI PubMed PMID: 2309736, 1990 Feb.
• Image credit Online Archive of California.

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Source DES litigation, legal cases.
• Diethylstilbestrol DES studies listed by topics and date of publication.

American journal of hospital pharmacy, Ethics, 1989

Abstracts

…”One Sunday afternoon. Attendant Jones from the facility arrives at Lakeside Hospital with an order for a dose of diethylstilbestrol (DES) that clearly is intended for postcoital contraception. Pharmacist Smith, the only pharmacist on duty, informs Attendant Jones that he will not fill the prescription…

… When Dr. Doe, the prescribing physician, learns of Pharmacist Smith’s response, she telephones Pharmacist Smith and explains that the drug must be administered that afternoon; the patient for whom the prescription is intended had sexual intercourse approximately two days ago, and the drug most likely will not be effective if it is administered on Monday. Pharmacist Smith remains adamant in his refusal to fill the prescription.

Is it within Pharmacist Smith’s rights to refuse to fill this prescription ?“…

Read the full paper (free access) on watermark.silverchair, 1989 Jul.

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.

The Stilbestrol Story, Albrecht W. Schmitt, M.D., 1974

Abstract

Finally, a few comments should be made concerning DES-related problems. First, the morning-after pill, which should better be called the post-ovulatory pill, needs to be mentioned. As we know, there are a great number of practitioners and clinics who use DES for the prevention of pregnancies in girls who come to the office or clinic after sexual exposure, specifically rape or incest. DES should not do any harm to these patients as the drug is given at a time when the duct systems of the genital organs are not yet being formed. With this fact in mind, there should be no objection to the use of DES in such emergencies. However, considering the potential teratogenic effect of DES, it should be advised against the routine use of DES as a morning-after pill, as expressed in a pamphlet recently distributed by Eli Lilly and Company, the only manufacturer of DES, according to the current PDR.

Another point of importance is the feeding of cattle and sheep with DES. The FDA banned stilbestrol for this purpose in 1972 because small amounts of DES had been found in the livers of DES-fed livestock. This ban is, of course, difficult to enforce but all possible ways should be used to prevent meat from DES-fed or implanted animals from reaching the food markets.

The final point concerns the question of whether a patient with a history of DES-exposure in utero should be permitted to take the birth control pill. The author goes along with Herbst that there is no evidence that the pill has ever changed adenosis into clear cell carcinoma. However, on the basis of our knowledge, that clear cell carcinoma develops mostly after puberty when the ovaries produce an increased amount of endogenous estrogen, patients with DES history should be advised against the pill; and an alternate means of contraception should be used.

Sources

• Read the full paper (free access) : The Stilbestrol Story, Dept. of Obstetrics & Gynecology. The Medical College of Pennsylvania., doi/pdf/10.1177/019262337400200201, June 1974.
• Image credit avert.

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.

Correspondence, Eugene F Diamond M.D., Stritch School of Medicine, Loyola University, 1985

Sources

• Estrogen treatment for victims of rape, The New England journal of medicine, NCBI PubMed, PMID: 3974688, 1985 Apr 11.
• Image credit headtopics.

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.

Physician Advisory: Health Effects of the Pregnancy Use of Diethylstilbestrol

Abstract

Although the doses and duration of DES use for postcoital contraception are less than the doses and duration which were commonly used when DES was prescribed for pregnancy complications, health risks may be similar.

It also is possible that women may take the drug as a postcoital contraceptive when already pregnant from previous intercourse. In such cases the potential offspring of such pregnancy would be exposed to the risks previously described.

Additionally, there is controversy over the efficacy of the drug for postcoital contraception and over the validity of studies showing it to be effective for that purpose. In light of these considerations, the following recommendations are made:

Postcoital contraception with estrogens in any woman should be restricted to situations where no alternative is judged acceptable by a fully informed patient and her physician.

Thorough birth control counseling should accompany or follow any prescription of estrogens for postcoital purposes. A principal objective of such counseling should be to discourage women to whom the drug is administered from considering it as a routine method of contraception upon which to rely in the future.

Sources

• Full study (free access) : Physician Advisory: Health Effects of the Pregnancy Use of Diethylstilbestrol, Taylor & Francis Online, doi.org/10.3109/15563657908992452, 1979.
• Image credit columbusmuseum.

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.

DES used as an emergency contraception, Germany, 1984

Abstract

Postcoital contraception, or “interception” of the blastocyte before it implants in the uterus, is an effective method of contraception which is recommended for more frequent use, though only as indicated in emergencies such as rape, rupture of condom, 1st sexual experience without contraception, and isolated sexual relations without contraception.

General contraindications include already existing pregnancy and multiple risk of pregnancy in a single menstrual cycle.

There are 3 types of accepted hormonal postcoital contraception–estragens alone, progestagens alone, and combined estrogen and progestagen– which must begin within 48-72 hours after intercourse.

Estrogens most commonly suggested are

1. diethylstilbestrol (DES), 50 mg daily for 5 days,
2. conjugated estrogens, 10 mg daily for 5-6 days,
3. and ethinyl estradiol (EE), 5 mg daily for 5 days.

The high dosages required for effectiveness can cause complications, the most severe being ectopic pregnancy, but the failure rate of this method is only .7%.

The failure rate using progestagens alone is inversely proportional to the administered dose (i.e., 1% for 1 mg of D-norgestrel or levonorgestrel). Norgestrel and quingestanol are used most frequently with the most severe complication being disturbance of the cycle. Oral administration of the combination pill containing .05 mg EE and .25 mg D-norgestrel, at a 12-hour interval is the most widely accepted hormonal method, as the short treatment period assures patient compliance, the low estrogen dosages reduce the occurrence of side effects, although 40-50% still experience nausea, and the contraindications are the same as for general estrogens-progestagens.

Intrauterine postcoital contraception involves insertion of a coil, which prevents implantation of the blastocyte in the uterus, and has been shown to be 100% effective, although no extensive series have been publicized as compared with the hormonal methods.

Where postcoital contraception is used, a detailed history should be obtained to determine risk of pregnancy and possible contraindications, and the patient should be informed of the side effects and procedural methods.

Sources

• Postcoital contraception (without prostaglandins), Der Gynakologe, NCBI PubMed, PMID: 6489843, 1984 Sep 17.
• Image credit amazon

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.

DES used as an emergency contraception, Denmark, 1983

Abstract

Postcoital contraception (PC) has become more effective in recent years and is recommended for women who have had unprotected coitus between the 8th and 17th days of their cycles. Vaginal douche using a spermicide solution is ineffective as it has resulted in a 37% pregnancy rate.

Estrogens are far more effective: Diethylstilbestrol (DES), taken in doses of 25-50 mg daily for 5 days, e.g., 10 mg of conjugated estrogens 3 times daily, and 2.5 mg ethinyl estradiol 2 times daily for 5 days 24-72 hours after coitus, has resulted in a .5-1.5% pregnancy rate. Side effects, however, include nausea, vomiting, mastalgia, menorrhagia, extrauterine pregnancy, and adenocarcinoma in daughters of DES-treated women.

Gestagens, such as .15-.40 mg of d-norgestrel taken 3 hours after coitus, can be used as a form of planned PC. In an experiment, an estrogen-gestagen preparation consisting of 50 mcg ethinyl estradiol and 500 mcg dl-norgestrel taken 12-72 hours after coitus produced a .9% pregnancy rate in 1300 menstrual cycles with few serious side effects. Copper 7 or copper-T IUDs also prevent the implantation of the fertilized egg, and, when used within 5 days after coitus, produced only 1 pregnancy in 727 cases.

The ideal future PC would be a preparation that inhibits either ovulation or nidation and has limited side effects. Among some promising agents are a luteinizing hormone-releasing factor agonist as well as natural and synthetic prostaglandins; however, until their cardiovascular and gastrointestinal side effects have been ameliorated, their routine use is unlikely.

Sources

• Postcoital contraception, Ugeskrift for laeger, NCBI PubMed, PMID: 6612804, 1983 Jun 13.
• Image credit bigbible

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.

DES has received wide attention

Abstract

Approaches to postcoital interception are discussed.

High dose estrogen only regimens have an overall failure rate of .7%. The mechanism of action is speculated to include luteolysis and disordered endometrial development. Although several preparations have comparable potency if administered within 72 hours, diethylstilbestrol (DES) has received wide attention. As with other estrogen regimens, the main deficiency of DES relates to the need to consume high doses of estrogen, with its attendant potential risks and side effects.

Combination regimens, under which women are treated with 2 doses of 2 tablets each containing 1 mg dl-norgestrel and 100 mcg ethinyl estradiol (EE), are being investigated. Experience with 1300 treatment cycles indicated a failure rate of 1.6%. Advantages include a reduction in the duration of therapy, 12 hours versus 5 days; fewer tablets consumed, and a 125-fold reduction in consumed estrogen. Research is continuing on lower doses and nonoral administration. Progesterone receptor antagonists may be ideally suited for luteolytic interception and are being investigated. Administration of 50 mg of R2323 on days 15 to 17 over 2000 treatment cycles has shown a failure rate of 5%. Agonistic analog of gonadotropin-releasing hormone is being studied as a potential luteolytic interceptor. In a recent study, single or double subcutaneous administration between days 5-8 after the luteinizing hormone peak resulted in luteolysis in 96% of the treatment cycles.

Sources

• The morning after: novel hormonal approaches to postcoital interception, Fertility and sterility, NCBI PubMed, PMID: 6402385, 1983 Mar.
• Image credit engadget.

DES DIETHYLSTILBESTROL RESOURCES

• Source DES and pregnancy studies.
• Diethylstilbestrol DES studies listed by topics and date of publication.