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Headache in Pregnancy

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5001. A twelve-month comparative clinical investigation of two low-dose oral contraceptives containing 20 micrograms ethinylestradiol/75 micrograms gestodene and 20 micrograms ethinylestradiol/150 micrograms desogestrel, with respect to efficacy, cycle control (Abstract)

of estrogen combined with 150 micrograms desogestrel. This article presents interim data from centers in France and Austria, involving a total of 479 women and 4,991 cycles. Contraceptive reliability was good with both preparations. Two pregnancies occurred in the gestodene group, but neither were due to method failure. In the desogestrel group there were also two pregnancies, of which one was due to method failure. With respect to cycle control, there is a trend towards a lower incidence (...) of intermenstrual bleeding in the gestodene group. The incidence of spotting (scanty bleeding) during the important first three cycles was 3.5% lower in the gestodene group, and over the first six cycles, it was 7.6% lower. Amenorrhea was similar in both groups, but the incidence of dysmenorrhea was significantly lower in the gestodene group (p=0.001). Adverse events were similar in both groups, with headache, breast tension and nausea the most frequently reported symptoms. Body weight remained relatively

1995 Contraception Controlled trial quality: uncertain

5002. Updating the clinical experience in endometriosis--the European perspective. (Abstract)

. Clinical assessment, haematological and biochemical investigations were carried out during the 6 months of treatment and for a further 12 months' follow-up and are compared between the two groups. A total of 15 patients from the gestrinone group, including four patients with hirsutism, and 17 patients from the danazol group, including six patients with headache, withdrew because of adverse symptoms. An additional 22 patients, including 10 from the gestrinone group and 12 from the danazol group withdrew (...) because of lack of efficacy, pregnancy, elevated hepatic function tests or for reasons unrelated to the trial. Total American Fertility Society scoring showed an improvement of 73.3% in 101 patients receiving gestrinone and 72.7% in 99 patients receiving danazol. The results showed a significant reduction in the severity of dysmenorrhoea by the third month in the danazol group and at 6 months in both groups. There was a significant (P < 0.001) increase in weight observed in both groups during

1995 British journal of obstetrics and gynaecology Controlled trial quality: uncertain

5003. Dexamethasone prevents relapse after emergency department treatment of acute migraine: a randomized clinical trial. (Abstract)

for this randomized, double-blind trial. The study was conducted in the ED of 2 community hospitals, 1 of which was a tertiary referral centre. Exclusion criteria included pregnancy, focal findings, fever, meningismus, allergy to the study drug, active peptic ulcer disease and diabetes mellitus. Demographic and clinical data, including headache severity, were recorded. After abortive therapy (antiemetics, intravenous nonsteroidal agents, dihydroergotamine or opioids), blinded nurses administered dexamethasone (24 (...) Dexamethasone prevents relapse after emergency department treatment of acute migraine: a randomized clinical trial. To determine whether the addition of intravenous dexamethasone to standard emergency department (ED) migraine therapy would decrease the incidence of severe recurrent headache 24 to 48 hours after initial treatment.Patients aged 19 to 65 years whose headache was severe enough to require parenteral therapy and who met International Headache Society migraine criteria were eligible

1999 CJEM Controlled trial quality: predicted high

5004. A randomised controlled trial of intramuscular syntometrine and intravenous oxytocin in the management of the third stage of labour. (Abstract)

A randomised controlled trial of intramuscular syntometrine and intravenous oxytocin in the management of the third stage of labour. To compare the efficacy and safety of intravenous oxytocin with intramuscular syntometrine in the management of the third stage of labour.A prospective randomised trial.A university teaching hospital.A total of 991 women having a singleton pregnancy and vaginal delivery were randomised by a computer-generated number to receive either 1 ml syntometrine (...) intramuscularly or 10 units of intravenous Syntocinon after delivery of the anterior shoulder of the fetus.Blood loss during delivery, rate of postpartum haemorrhage, need for repeated oxytocics, haemoglobin level before and 24 hours after delivery, duration of third stage, need for manual removal of placenta and sides effects including hypertension, nausea, vomiting, headache and chest pain.The use of intravenous oxytocin was associated with a reduction in postpartum blood loss (P < 0.001

2002 BJOG Controlled trial quality: predicted high

5005. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. (Abstract)

(group B) were studied in 1118 volunteers. Mild side effects such as nausea, vomiting, lower abdominal pains, menorrhagia, dizziness, headache, and breast tenderness were reported. Significantly more women in the high-dose group reported headache, breast tenderness, and heavy menstrual flow. Eleven pregnancies (1.0%) were reported (7 in group A and 4 in group B). The crude relative risk of pregnancies was similar in the two groups (RR = 0.71, 95% CI = 0.32-1.55; p > 0.05) [corrected]. On the other (...) hand, the estimated effectiveness rate of 86.80% in group A was significantly lower than the 92.99% for group B (p < 0.05). The pregnancy rates increased with delay in starting treatment and if further acts of unprotected sexual intercourse took place after treatment. It was concluded that both regimens were effective and safe.

2002 Contraception Controlled trial quality: uncertain

5006. Clinical comparative study of oral contraceptives containing 30 microg ethinylestradiol/150 microg levonorgestrel, and 35 microg ethinylestradiol/250 microg norgestimate in Thai women. (Abstract)

with the 30 microg EE/150 microg LNG group, but was not statistically significant. There was no amenorrhea nor pregnancies occurring in either group. No significant changes in body weight or blood pressure were found in both groups. The incidence of adverse events in both groups was low and tended to decrease with time. Statistically significant differences were observed for headache and dizziness, which occurred more in the 30 microg EE/150 microg LNG group. In conclusion, 35 microg EE/250 microg NGM (...) provides reliable contraceptive efficacy. It also provides good cycle control equal to 30 microg EE/150 microg LNG with a lower incidence of minor adverse effects such as headache and dizziness compared to 30 microg EE/150 microg LNG.Copyright 2002 Elsevier Science Inc.

2002 Contraception Controlled trial quality: uncertain

5007. Safety and efficacy of fluoxetine in patients who receive oral contraceptive therapy. (Abstract)

for oral contraceptive use versus no oral contraceptive use were headache, asthenia, and pain. There was not a statistically significant interaction in the incidence of unintended pregnancies (P =.111) or in the changes from baseline in HAMDD-17 scores.There is no clinical evidence that concomitant use of oral contraceptives and fluoxetine affects the safety or efficacy of either agent. (...) Safety and efficacy of fluoxetine in patients who receive oral contraceptive therapy. Because many women who receive pharmacologic therapy with antidepressants are also prescribed oral contraceptives, it is important to assess the risk of clinically significant drug interactions. We reviewed the United States fluoxetine clinical trial database, specifically analyzing women ages 18 to 45 years, for differences in safety, antidepressant efficacy, and unplanned pregnancies that were associated

2002 American journal of obstetrics and gynecology Controlled trial quality: uncertain

5008. Chemical ripening of the cervix with intracervical application of sodium nitroprusside: a randomized controlled trial. (Abstract)

Chemical ripening of the cervix with intracervical application of sodium nitroprusside: a randomized controlled trial. Nitric oxide (NO) has been found to be involved in the processes of cervical ripening. In a randomized, placebo-controlled study, cervical softening by an intracervical application of sodium nitroprusside, one of the most clinically potent and effective NO donor agents, was evaluated. A total of 36 primigravid women undergoing pregnancy termination between 9 and 12.5 weeks were (...) (dynamometer). Blood pressure was measured. Adverse events were recorded until 2 h after surgery. Women treated with both doses of nitroprusside gel showed values of cervical resistance significantly lower than those treated with placebo gel, at any tested diameter. No differences were found between subjects treated with the two different doses of nitroprusside. No significant consistent changes in blood pressure were induced by either dose of nitroprusside. No headaches were found in subjects treated

2000 Human reproduction (Oxford, England) Controlled trial quality: uncertain

5009. Randomized comparison of glyceryl trinitrate and prostaglandin E2 for cervical ripening at term. (Abstract)

Randomized comparison of glyceryl trinitrate and prostaglandin E2 for cervical ripening at term. To estimate the adverse effects of glyceryl trinitrate compared with prostaglandin (PG) E2 vaginal tablet for cervical ripening in term pregnancy.One hundred ten women with term pregnancies referred for induction of labor with Bishop scores of 6 or less were randomly assigned to receive a 500-microg glyceryl trinitrate tablet vaginally (n = 54) or a 3-mg PGE2 tablet vaginally (n = 56), every 6 hours (...) effects, including headache and palpitations, were more frequent with glyceryl trinitrate than with PGE2. The cesarean rate was not significantly different between groups.Cervical ripening with glyceryl trinitrate resulted in fewer episodes of tachysystole, but there were significantly more minor side effects. It can be used for cervical ripening at term, but it was not as effective as PGE2.

2000 Obstetrics and Gynecology Controlled trial quality: uncertain

5010. Latin american experience with two low-dose oral contraceptives containing 30 microg ethinylestradiol/75 microg gestodene and 20 microg ethinylestradiol/150 microg desogestrel. (Abstract)

in Argentina, Brazil, Chile, and Mexico. Contraceptive efficacy was good with both formulations. Two pregnancies occurred in the desogestrel group but were not due to method failure. With respect to cycle control, the incidence of intermenstrual bleeding was higher during the first 3 cycles in the desogestrel group; it was significant (p <0.01) during the first 3 days of the cycle for a normal or heavy bleeding only in the Mexican group. Amenorrhea was not reported for any group, but the incidence (...) of dysmenorrhea was significantly higher (p <0.01) in the Brazilian desogestrel group (13.8%) and was significantly lower (p <0.01) in the Mexican gestodene group (8.5%). Adverse events were similar in all the countries with headache, breast tension, and nausea, the most frequently reported symptoms. The range of mean increase in body weight varied from 0.2 kg in the Argentine group to 2.6 kg in the Chilean group (95% confidence limit, +/- 2.51) in the gestodene group, and 0.2 kg in the Argentine group to 2.5

2000 Contraception Controlled trial quality: uncertain

5011. RU 486 (mifepristone): clinical trials in China. (Abstract)

RU 486 (mifepristone): clinical trials in China. Four multicentre clinical trials on interruption of early pregnancy (less than or equal to 49 days of amenorrhea) using RU 486 have been conducted in China, including 2321 subjects. The data from trials 1, 2 and 4 are presented here. RU 486 (600 mg as a single dose) was given to 299 women. A further 422 women were given RU 486 (600 mg) plus a vaginal suppository containing the Chinese domestic prostaglandin PGO5 (1 mg) 36-60 hours later. Complete (...) loss (n = 21, 52 ml vs n = 13, 117 ml). Two patients from the RU 486+PG group and 4 given RU 486 alone suffered heavy bleeding, necessitating emergency curettage. No transfusions were required. The time elapsed between RU 486 intake and expulsion of the conceptus was significantly shorter in the RU 486+PG group (n = 97, 31 days) than that in the RU 486 alone group (n = 95, 4.4 4.4 days). Main side effects, nausea/vomiting and headache/dizziness, were mainly due to RU 486. PG increased the incidence

1989 Acta obstetricia et gynecologica Scandinavica. Supplement Controlled trial quality: uncertain

5012. A comparative study of Norinyl 1/35 versus Brevicon in Panama City, Panama. (Abstract)

) intermenstrual bleeding, nausea, headaches, dizziness and vaginal discharge than women in the Norinyl 1/35 group. The total discontinuation rate at 12 months was 28.0 for the Norinyl 1/35 group and 46.7 for the Brevicon group, and this difference was significant (p less than .01). Also, significantly more women (p less than .01) in the Brevicon group discontinued for menstrual problems than women in the Norinyl 1/35 group. No pregnancies were reported during this study. While both oral contraceptives appear

1987 Contraception Controlled trial quality: uncertain

5013. A triphasic oral contraceptive pill, CTR-05: clinical efficacy and safety. (Abstract)

the selection criteria, were evaluated for six cycles, in an open-label, randomized study. Volunteers using CTR-05 were studied for 13 additional cycles for efficacy and safety.No serious adverse effects were observed in either group. The incidences of other drug-related adverse effects, such as headache and nausea, were transient in both groups. CTR-05 did not lower levels of high density lipoprotein (HDL) cholesterol. This may be attributed to the lower androgenicity of its progestin component (...) , desogestrel. No pregnancies were reported in either group. Clinical and laboratory parameters remained within normal limits in both groups. In the CTR-05 group, the lower dose of ethinylestradiol did not affect the safety, efficacy and acceptability of the product.Desogestrel, with little estrogenic activity and only minimal androgenic activity, leads to lipoprotein changes, resulting in a favorable cardiovascular profile, as well as minimal androgen-related effects, such as hirsutism and acne.

1996 The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception Controlled trial quality: uncertain

5014. Effect of vitamin B6 on the side effects of a low-dose combined oral contraceptive. (Abstract)

Effect of vitamin B6 on the side effects of a low-dose combined oral contraceptive. Analogous to recommendations for treatment of side effects of early pregnancy and premenstrual syndrome, use of vitamin B6 has been recommended for the treatment of side effects of oral contraceptive (OC) use. A randomized, triple-blinded controlled trial of 124 women was done to evaluate the effect of taking 150 mg of vitamin B6 daily for 30 days on the severity of nausea, headache, vomiting, dizziness (...) difference in the reductions found in the vitamin B6 and the placebo groups, although reductions in the severity of headache and dizziness were greater in the B6 group. The decrease in the severity of all OC side effects can be explained more by a placebo effect than by a marginal pharmacological effect of the vitamin B6.

1997 Contraception Controlled trial quality: uncertain

5015. Oral fluids prior to day surgery. The effect of shortening the pre-operative fluid fast on postoperative morbidity. (Abstract)

differences between the two groups. In conclusion, pain, nausea and headache scores are low following total intravenous anaesthesia with propofol and alfentanil for termination of pregnancy and these were unaffected by the administration of 150 ml of clear fluid given approximately 1.5 hours pre-operatively. (...) Oral fluids prior to day surgery. The effect of shortening the pre-operative fluid fast on postoperative morbidity. One hundred day surgical patients undergoing first trimester termination of pregnancy were randomly allocated to receive either 150 ml of clear fluid 1.5-2 hours before anaesthesia or to remain fasted from midnight the night before. Patients were anaesthetised using a total intravenous technique which consisted of propofol and alfentanil. No adverse intra-operative events were

1991 Anaesthesia Controlled trial quality: uncertain

5016. Treatment of hypertension in patients with pre-eclampsia: a prospective parallel-group study comparing dihydralazine with urapidil. (Abstract)

is a difficult task with partially unknown hazards. In some other countries combined alpha- and beta-blockers are also used. Taking into account that some patients with pre-eclampsia do not respond to dihydralazine and the drug has serious side-effects like headache and reflex tachycardia, there is some need for developing alternative treatment strategies using drugs that are more adequate for pregnancy than dihydralazine.Urapidil is a post-synaptic alpha 1 adrenoceptor antagonist, which is widely used (...) Treatment of hypertension in patients with pre-eclampsia: a prospective parallel-group study comparing dihydralazine with urapidil. The primary objective of treatment in women with severe hypertension and pre-eclampsia is to prevent complications such as encephalopathy and haemorrhage. In many countries dihydralazine is considered the drug of choice for treating hypertension in pregnancy, because it now has been used safely for about 30 years, and the introduction of a new drug in pregnancy

1998 Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association Controlled trial quality: uncertain

5017. Effect of different insertion regimens on side effects with a combination contraceptive vaginal ring. (Abstract)

during the first night [27%]). Transient vomiting occurred in about 10% of women in the first 24 h after first insertion of a new ring. The incidence and severity of nausea was greatly reduced in cycle 2 with each regimen (6% to 9% of women). Nausea could be prevented by overnight soaking of the ring in water before use. Other side effects such as headache, dizziness, uterine cramps, breakthrough bleeding, weight gain, and ring expulsion occurred with similarly low frequency in all three insertion (...) groups. One pregnancy occurred with probable ovulation between cycles 5 and 6, the only pregnancy recorded to date in studies with this ring. The study demonstrated that this effective and generally well tolerated CVR causes a relatively high incidence of transient nausea after insertion of a new ring, which is probably due to accumulation of ethinyl estradiol on the ring surface during storage. Acceptability is still high, and this particular CVR merits further development.

1997 Contraception Controlled trial quality: uncertain

5018. The performance of levonorgestrel rod and Norplant contraceptive implants: a 5 year randomized study. (Abstract)

The performance of levonorgestrel rod and Norplant contraceptive implants: a 5 year randomized study. A new contraceptive (LNG rod implants, Jadelle, Leiras Oy's registered trademark for rod implants) was prospectively evaluated in randomized 5 year comparison with Norplant (Population Council's registered trademark for contraceptive implants releasing levonorgestrel) capsule implants. The study involved 1198 women at seven centres. No pregnancies occurred in the first 4 years. At 5 years (...) , the cumulative pregnancy rate was 1 per 100 users or less for each regimen. Annual discontinuation rates averaged 11-12 per 100 users (P > 0.05), corresponding to 5 year continuation rates of 55.1 for rods and 53.0 per 100 for capsules. Mean annual discontinuation rates for menstrual disturbances were 3.5 and 4.2 per 100 for rod and capsule implants respectively (P > 0.05), and mean annual removal rates for medical problems were 3.5 and 3.0 per 100 (P > 0.05) respectively. Apart from menstrual problems

1998 Human reproduction (Oxford, England) Controlled trial quality: uncertain

5019. A comparative study of two low-dose combined oral contraceptives: results from a multicenter trial. (Abstract)

postpartum and randomly allocated to one of the above OCs. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Baseline sociodemographic characteristics were similar for both groups, as well as compliance. There were nine unintended pregnancies reported; eight of these occurring in the NA group. Adverse experiences were minor with headaches and dizziness being the most common complaints; frequency of reports was similar in both groups. The group taking the NG-based OC had

1993 Contraception Controlled trial quality: uncertain

5020. Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR). (Abstract)

contraindications to IUDs.Incidence of complaints, conditions, and rates of specific termination for each IUD.Subjects recorded menstrual events, and clinical staff registered all complaints and conditions found on examination at four first-year clinic visits and at semiannual visits thereafter. Difference in rates were analyzed by chi 2 statistics.Annual pregnancy rates for each IUD averaged 0.2/100 women whereas upper genital tract infection occurred at rates of 0.6 to 0.7 per 100 years of use (...) . The levonorgestrel-releasing IUD significantly decreased bleeding and spotting days in comparison with historical data for noncontraceptors and with the copper-medicated IUD. Dysmenorrhea, vaginitis, and myoma in women with the levonorgestrel IUD were markedly decreased in comparison with the experience of copper IUD users. Significantly higher rates of amenorrhea, delayed ovarian follicular atresia, skin and hair conditions, and headache were observed with the steroid IUD than with the copper-releasing IUD

1994 Fertility and sterility Controlled trial quality: uncertain

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