The use of a new progestogen, norgestrel as an oral contraceptive among Filipino women

1. Norgestrel 0.5 mg. combined with ethinylestradiol 0.05 mg. is an effective oral contraceptive agent2. The preparation is safe with relatively few and minor side effects3. The preparation is well accepted and no patient dropped out because she could not tolerate the drugs. (Conclusions)

Timing of postpartum tubal sterilization using the Filshie clips: an analysis of data from two developing-country centers.

Two-hundred-ninety-seven women at a Panamanian center and 148 women at a Philippine center had their tubal sterilization performed during their postpartum hospital stay after an uncomplicated vaginal delivery of a live birth. The sterilizations were all performed with the use of the Filshie clip via minilaparotomy. The timing of the sterilization varied from two hours to six days after delivery. At each of the two centers, women sterilized within 48 hours after delivery were compared with those sterilized at 49 or more hours with respect to surgical difficulties, tubal injuries, complications/complaints, technical failures and lengths of hospitalization after sterilization and before discharge. The one-year gross cumulative pregnancy rates were also compared. No significant differences were detected in any of the above outcome variables between the two timing groups at each center. While the data suggest that tubal sterilizations by the Filshie clip performed two to six days following childbirth are as safe and effective as those performed within 48 hours of delivery, further studies are urged.

PIP: 297 women at a Panamanian center and 148 women at a Philippine center had their tubal sterilizations performed during their postpartum hospital stays after uncomplicated vaginal deliveries of livebirths. The sterilizations were all performed with the use of the Filshie clip via minilaparotomy. The timing of the sterilizations varied from 2 hours-6 days after delivery. At each of the 2 centers, women sterilized within 48 hours after delivery were compared with those sterilized at 49 or more hours with respect to surgical difficulties, tubal injuries, complications/complaints, technical failures, and lengths of hospitalization after sterilizations and prior to discharge. The 1 year grossed cumulative pregnancy rates were also compared. No significant differences were detected in any of the above outcome variables between the 2 timing groups at each center. While the data suggest that tubal sterilizations by Filshie clip performed between 2-6 days postpartum are as safe and effective as those performed within 48 hours of delivery, further studies are necessary.

The reliability of menses to indicate the return of ovulation in breastfeeding women in Manila, The Philippines.

Demographic studies generally use menses to indicate the return of fertility during breastfeeding. In a prospective study of 40 breastfeeding women in Manila, the resumption of ovarian activity was monitored by urinary hormone assays, and menstrual status was determined by weekly interview. For the women who menstruated before six months postpartum, first menses was not a good indicator of ovulation because there was a high proportion of anovular menses (67 percent), and the lag between anovular first menses and subsequent ovulation was 15.7 (+/- 4.4) weeks. After six months postpartum the proportion of anovular first menses declined to 22 percent, and the lag between anovular first menses and ovulation was 7.3 (+/- 4.6) weeks. If all anovular and ovulatory menstrual episodes are considered, the mean interval between first observed menses and first ovulation was 8.4 weeks during the first six months postpartum and only 0.1 week after six months. Thus, in breastfeeding women, menses is an inaccurate proxy measure for the timing of fertility return before six months postpartum, but a good indicator of the resumption of ovulation after six months.

Risk of ovulation during lactation.

60 breastfeeding mothers in Baltimore and 41 in Manila recorded their infant feeding patterns daily, and gave additional information at weekly interviews. Ovarian activity was monitored by assays for hormone metabolites in daily urine samples. On average, women in Baltimore breastfed less often but for longer at each feed than women in Manila, and the mean times until ovulation were 27 and 38 weeks post partum. 41% of first ovulations had luteal phase defects. Anovular first menses were common (45.1%) during the first 6 months post partum but the rate fell greatly thereafter. The risk of ovulation was reduced by a higher frequency of breastfeeds, longer duration of each feed, and less supplementary feeding. During the first 6 months post partum, amenorrhoeic women had low risks of ovulation (below 10%) with partial breastfeeding, and exclusive breastfeeding reduced the risk to 1-5% with either frequent short feeds or infrequent longer feeds. However, if the woman started menstruating before 6 months post partum, or if she continued breastfeeding beyond 6 months, the risk of ovulation rose, and contraception would be needed.

PIP: The factors predicting the return of ovulation during lactation were investigated in 60 breast feeding mothers from Baltimore, Maryland, and 41 mothers from Manila, the Philippines. The women in Manila breast fed more frequently (11.0 mean daily feeds) than those in Baltimore (5.8 feeds) throughout the first postpartum year. However, during the first 6 months, the average length of an individual breast feed was longer among US women. Although both groups gave few supplementary feeds during the first 20 weeks after delivery, more non-bottle feeds were given thereafter in Manila. Use of bottle feeds was similar in both groups. Women who first ovulated before 6 months gave significantly fewer mean daily breast feeds during this period (8.5) than those who first ovulated after this point (10.7). Women who first ovulated before 6 months also had a lower percentage breast feeds of total feeds (84.2%) than women who first ovulated later (88.2%). The mean duration of amenorrhea was 25.3 weeks in Baltimore and 31.7 weeks in Manila; the average times before first ovulation were 27.0 weeks and 38.0 weeks, respectively. Multivariate analyses showed that the length of suckling per feed, the daily number of breast feeds, and the proportion of breast feeds were all significantly and independently associated with a low risk of ovulation. Up to 6 months postpartum, exclusive breast feeding reduced the risk of ovulation by 98-99% during amenorrhea and by 94-97% after anovular menstruation. Only amenorrheic women practicing exclusive breast feeding during the first 6 postpartum months can achieve a pregnancy rate below 2%. These findings suggest that contraceptive use is indicated among women who resume menstruating before 6 postpartum months or continue breast feeding beyond 6 months.

A 3-year evaluation of the TCu380Ag and the Cu-7.

The TCu380Ag and the Cu-7 intrauterine devices (IUDs) were evaluated in a randomized comparative clinical trial. A total of 198 women who had not recently been pregnant entered the trial in Manila, Philippines and were followed-up through 3 years postinsertion. The 36-month follow-up rates were impressively high at 80.3 for TCu 380A users and 76.7 for users of the Cu-7. Although the two IUDs demonstrated statistically similar termination rates, the findings suggest a higher efficacy for the TCu380Ag. Gross cumulative life-table pregnancy rates were 0.0 and 4.5 for the TCu380Ag and Cu-7, respectively, at 3 years. Overall 3-year continuation rates were 74.3 and 64.9 for users of the respective devices.

A comparative analysis of three different dose combinations of oral contraceptives.

Three different low-dose formulations of oral contraceptives were compared to determine the most suitable preparation for Filipino women as reflected in the first year continuation rates, incidence of side effects and failure rates. A total of 1,800 subjects were enrolled in the study from 18 health centers in six provinces in two regions of the Philippines, covering a total of 18,282 women-months of use. Sociodemographic characteristics were comparable. The monophasic levonorgestrel group showed the best performance followed by the triphasic preparation. The norethindrone group consistently showed higher drop-out rates, which may be due to the relatively higher incidence of side effects. For all three preparations, bleeding irregularities were low. There were no major side effects and no pregnancy was reported in one year of use. Noted was a distinct regional and provincial difference in recruitment and follow-up performance, possibly due to clinic, client or program factors.

Postpartum IUD insertions in Manila, Philippines.

In comparative IUD trials conducted in the Philippines, IUDs were inserted immediately postpartum (within ten minutes postplacenta). The first study was designed to compare the IPCS-52 mg (Intrauterine Progestasert Contraceptive System) IUD with the TCu200 when inserted either by hand or with an inserter. Follow-up continued for three years because the IPCS model was designed to release progesterone for this length of time. There was one suspected pregnancy for which the IUD was removed during the study period. The expulsion rates were higher in the IPCS groups than in the TCu groups (p less than or equal to 0.05) and they were higher in the hand insertion groups than in the inserter groups (p less than or equal to 0.05). The second study was a comparison of the Lippes Loop D and a Delta Loop, modified by the addition of three biodegradable suture projections (made of Ethicon #2 chromic material) on the upper arms of the device. The purpose of this modification was to lower the expulsion rates associated with postpartum insertions. The expulsion rates for these two devices were comparable. There were no difficulties during insertion in either study, and few complaints were reported at follow-up. These two studies demonstrated that immediate postpartum IUD insertion proved a safe, effective means of postpartum contraception.

Clinical assessment of a new triphasic oral contraceptive.

One hundred twenty women completed 901 woman-months of birth control with a new triphasic oral contraceptive. No pregnancies occurred, and good cycle control was achieved. Spotting and breakthrough bleeding were minimal, and amenorrhea did not occur. Changes in body weight and blood pressure were not statistically significant. The triphasic compound was well tolerated. Headache and dizziness were frequent complaints during the initial cycles but tended to subside within a few months.

PIP: The efficacy and safety of a new triphasic oral contraceptive (OC) were evaluated in a trial involving 120 women ages 18-33 years for a total of 901 woman-months of observation. 1 monthly cycle of this triphasic OC provides 6 tablets of 30 mcg ethinyl estradiol (EE) and 50 mcg levonorgestrel (LNg), 5 tablets of 40 mcg EE and 75 mcg LNg, and 10 tablets of 30 mcg EE and 125 mcg NNg. No pregnancies were reported during treatment. Cycle duration was significantly shorter during than before treatment. Before treatment, 88.6% of subjects had cycles of 29-32 days; after treatment, 74.3% had cycles of 20-28 days. The duration of menstruation was 2-5 days in 96.9% of treatment cycles, and the amount of flow was light to moderate in 94.2%. Breakthrough bleeding occurred in 0.4% and spotting in 1.0% of cycles; there was no amenorrhea. Side effects most frequently reported were headache (13.3%) and dizziness (8.2%). Changes in body weight and blood pressure were minimal.

A program of IUD insertions by paraprofessionals and physicians in the Philippines.

A program of IUD insertions by paramedics and physicians was undertaken at the José Fabella Memorial Hospital. Both Lippes C and D were inserted in the postpartum and interval periods. Results show that paramedics can safely and effectively perform IUD insertions, although there are indications of a need to periodically monitor, and perhaps retrain, personnel, be they paramedic or physician, in the techniques of IUD insertion.

Experience with minilaparotomy in the Philippines.

This paper presents the socio-demographic characteristics, medical histories, and clinical data on 651 women sterilized by interval minilaparotomy procedures in Manila, Philippines. About two thirds of the procedures were performed with local anesthesia; the Pomeroy technique was used for tubal ligation. In 2.8% of the patients, salpingectomy or fimbriectomy was performed on one side because of surgical difficulties and complications. Surgical difficulties were encountered in 19.8% of the procedures; adhesions (4.3%) and bowel interference (4.0%) were the most frequent causes of surgical difficulty. Complications occurred during surgery in 1.7% of the procedures. Early postoperative complications were noted in 9.1% of the cases. None of the patients required readmission to the hospital. While 612 women were followed up at 6 months, 299 were followed up at 12 months. One women (0.2%) became pregnant after sterilization; at repeat minilaparotomy, ligation of the left round ligament rather than the tube was observed. Pelvic surgery, other than pregnancy-related surgery, during the year following sterilization was reported for one patient who underwent exploratory laparotomy with appendectomy and oophorocystectomy. Menstrual pattern changes were minimal. The results of this study suggest that tubal ligation via minilaparotomy is practical, safe, and effective.

The LEM device in an immediate postpartum contraception program.

Experience with the LEM intrauterine device in an immediate postpartum program at the Jose Fabella Memorial Hospital, Manila, Philippines, is reported. During a 6-month period, the LEM was inserted in 1359 women immediately after normal term deliveries. The early expulsion rate was high, but removals for bleeding or pain were minimal. Pregnancy rates during the second 6 months of use were higher than those reported previously for postpartum insertions of the LEM device.

PIP: Experience with the LEm IUD in an immediate postpartum program is reported. During a 6-month period in 1973, the LEM device was inserted in 1359 patients immediately after term delivery. The LEM is made of polyethylene, impregnated with 20% barium sulfate. When inserted through a plastic tube it is a 2-dimensional device in the shape of a Gothic X. When the uterus involutes, the LEM becomes 3-dimensional. A double string is attached. At the end of 1 year, the gross pregnancy rate was 6.4%. This rate was greatest in the second 6 months of use. In 19 of the 25 cases of pregnancy the device was in place. In 1 case a stillbirth resulted at term. In 3 others spontaneous abortion had occurred and in 1 other abortion followed removal of the device by a physician. In 1 year, the gross expulsion rate was 20.6% of users, mostly during the first 6 months. Expulsions represented 76.2% of terminations of use. Removals for bleeding or pain were only 2.2%. In 1 case perforation of the uterine wall had occurred. After a Pomeroy procedure was done, this LEM was removed through the cervical os. The LEM IUD appears to be less effective than desired in pregnancy prevention. Design modifications are planned.

Clinical experience with ethinyl estradiol and d-norgestrel as an oral contraceptive.

One hundred eighty-one women received 30 mug of ethinyl estradiol plus 150 mug of d-norgestrel as an oral contraceptive for 21 days and then received no tablets for the next seven days for a total of 1,488 cycles. There were no pregnancies. Cycle control was good to excellent. Menstrual cycles lasted 25 to 32 days in 96.2% of treatment cycles. Menstruation lasted three to five days in 93.2% of the cycles, and it began three to five days after the last day of medication in 79.1%. The menstrual flow was moderate in 87%. Breakthrough bleeding occurred in 2.0% of treatment cycles, spotting in 0.1%, and amenorrhea in 0.8%. The incidence of adverse subjective symptoms was minimal and significant increases compared with the pretreatment cycle were noted only for nausea in the first two cycles and for nervousness in the second cycle of treatment. Overall incidence of nausea was 3.2% of treatment cycles.