Methyldopa versus nifedipine or no medication for treatment of chronic hypertension during pregnancy: A multicenter randomized clinical trial.

OBJECTIVE: To assess the maternal and fetal outcome in women with mild to moderate chronic hypertension on antihypertensive drug (methyldopa or nifedipine) therapy compared to no medication. METHODS: This multicenter randomized clinical trial was conducted at Menoufia University hospital, Shibin El-kom Teaching hospital and 11 Central hospitals at Menoufia governorate, Egypt.490 pregnant women with mild to moderate chronic hypertension were randomized into three groups; methyldopa group (n = 166), nifedipine group (n = 160) and control or no medication group (n = 164) who were followed from the beginning of pregnancy till the end of puerperium to record maternal and fetal outcome. RESULTS: Mothers in the control (no medication) group were more prone for the development of severe hypertension, preeclampsia, renal impairment, ECG changes, placental abruption and repeated hospital admissions (p < 0.001) when compared to mothers in both treatment groups (methyldopa and nifedipine). Neonates in the control (no medication) group were more prone for prematurity and admission to neonatal ICU (p < 0.001). CONCLUSION: Antihypertensive drug therapy is advisable in mild to moderate chronic hypertension during pregnancy to decrease maternal and fetal morbidity. When considering which agents to use for treatment, oral methyldopa and nifedipine are valid options.

Effects of a levonorgestrel intrauterine system versus a copper intrauterine device on menstrual changes and uterine artery Doppler.

OBJECTIVE: To compare the effects of a levonorgestrel-releasing intrauterine system (LNG-IUS) and a copper intrauterine device (Cu-IUD) on menstrual changes and uterine artery Doppler indices. METHODS: A randomized clinical trial was conducted at Menoufia University Hospital, Egypt, between December 2016 and August 2017. 306 multiparous women desiring intrauterine contraception were randomly assigned to LNG-IUS (n=152) or Cu-IUD (n=154). Uterine artery pulsatility index (PI) and resistant index (RI) were measured before use, and 3 and 6 months after insertion, and associations with abnormal bleeding were evaluated. RESULTS: Irregular bleeding was initially reported by 31 (74%) of 42 women in the LNG-IUS group, and heavy menstrual bleeding by 53 (67%) of 79 women in the Cu-IUD group. Incidence of abnormal bleeding decreased over the 6-month study period. Uterine artery PI was significantly correlated with abnormal bleeding at a cutoff of 1.35 with area under the curve (AUC) 0.93, sensitivity 88%, and specificity 100%, whereas uterine artery RI was significantly correlated with abnormal bleeding at a cutoff of 0.62 with AUC 0.1, sensitivity 96%, and specificity 100%. CONCLUSION: LNG-IUS-related abnormal bleeding was associated with changes in uterine artery blood flow that were not evident among Cu-IUD users. Pan African Clinical Trials Registry: PACTR201701001900640.

Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial.

OBJECTIVE: This study was conducted to evaluate the efficacy and safety of lactoferrin in comparison to ferrous sulphate for the treatment of iron deficiency anemia (IDA) during pregnancy. MATERIALS AND METHODS: This prospective, randomized, parallel-group, single-center study was conducted in the Department of Obstetrics and Gynecology at Menoufia University Hospital, Egypt and included a total of 200 pregnant women in the second trimester with IDA who were enrolled and randomly assigned either to receive 150 mg of dried ferrous sulphate capsules or lactoferrin 250 mg capsules once daily for eight consecutive weeks. The primary efficacy parameter was the amount of increase in hemoglobin concentration by 4 and 8 weeks, the adverse effects related to iron therapy and the patient compliance to the treatment. RESULTS: Total increase in Hb after 2 months with lactoferrin was higher (2.26 ± 0.51 g/dL) compared to ferrous sulfate (1.11 ± 0.22 g/dL) (p < 0.001). Gastrointestinal adverse events occurred more frequently with ferrous sulphate than the lactoferrin group (p < 0.001). The number of women requesting change the drug was higher in the ferrous sulphate group (p < 0.001). CONCLUSION: Lactoferrin was more effective than ferrous sulfate over a two-month period in pregnant women with IDA, with fewer gastrointestinal adverse events and better treatment acceptability.