ABSTRACT
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.
Subject(s)
Intrauterine Devices, Copper , Actuarial Analysis , Adult , Clinical Trials as Topic , Female , Follow-Up Studies , Humans , Philippines , Pregnancy , Random Allocation , Time FactorsABSTRACT
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.
Subject(s)
Intrauterine Devices , Postpartum Period , Adult , Female , Humans , Intrauterine Devices, Copper , Intrauterine Devices, Medicated , Philippines , Pregnancy , ProgesteroneABSTRACT
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.
Subject(s)
Contraceptives, Oral, Sequential/administration & dosage , Contraceptives, Oral/administration & dosage , Adolescent , Adult , Clinical Trials as Topic , Contraceptives, Oral, Sequential/adverse effects , Dizziness/chemically induced , Female , Headache/chemically induced , Humans , Menstrual Cycle/drug effects , PregnancyABSTRACT
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.
