Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso
Brief Summary: Intrauterine Growth Retardation is the most important determinant of mortality and morbidity in the neonatal period. It is also a very important factor in predicting nutritional status, health and development in childhood. It even influences health in adult life, contributing to the vicious cycle of disease and poverty. The high rate IUGR in DCs represents therefore a major public health problem. Maternal malnutrition is usually assumed to be a major determinant of the problem in these countries. An increasing amount of evidence points to the potential role played by micronutrient deficiencies during pregnancy. The adverse effect on birthweight of maternal iron deficiency anaemia, lack of zinc and lack of iodine have been documented. A similar effect is suspected for Vitamin A, Magnesium, Calcium, Copper,Thiamine, Pyridoxine and Folic acid. It seems that not one specific deficiency alone is responsible for this adverse effect, but rather a combination of them. Therefore, it is expected that covering needs of pregnant women by a multivitamin-mineral supplement will have an effect of public health importance on children's health.

This study has the objective of improving children's health by preventing intrauterine growth retardation through the provision of multivitamin-mineral supplements during pregnancy.

This research includes 2 constituents:

1. a pilot phase during which socio-anthropological, nutritional and epidemiological aspects of IUGR will be assessed through qualitative and epidemiological methods.
2. a double-blind, randomised, placebo-controlled trial, including 1215 pregnant women aimed at testing 3 hypotheses: supplementing pregnant women with a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy; covering nutritional needs of lactating women with a multivitamin-minerals mix during 3 months after delivery will improve health and growth of infants.

The trial is planned in Hounde District, Burkina Faso, in collaboration with Centre Muraz, which plays a leader role in research and services providing at the district level and in policy recommendations at the national level. This will ensure that the study findings are incorporated into on-going district programmes with possible replication at the national level. The research lasts from June 2003 to October 2006.


Options:
A: Inclusion Criteria:

All the women of child-bearing age (15-44 years) living in the study area (4 100) will be visited monthly to assess early pregnancy and will be invited to participate in the trial.

Exclusion Criteria:

Will be excluded from the study women :

* planning to move outside the district within the 2 years following the start of the trial.
* regularly using a contraceptive method.
* already pregnant at the start of the trial.
B: Inclusion Criteria:

* 18-35 years old
* Currently married
* Currently living in one of the 10 communes and intends to live in the areas for 24 months following recruitment
* Plans to have children in the next year
* Agrees to participate with informed consent

Exclusion Criteria:

* Currently pregnant
* Delivered in the previous six months
* Regularly consumed IFA or MM supplements in the past 2 months
* Severe anemia (Hb \< 7 g/L)
* History of high risk pregnancy including abruptio placenta, placenta previa, gestational diabetes, pregnancy induced hypertension, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use
* Chronic hematological diseases, hereditary defects of red cells or hemoglobin
C: Inclusion Criteria:

* Married women of reproductive age
* First pregnancy during time period of trial

Exclusion Criteria:

* Premenarchial girls
* Married women with a previous pregnancy enrolled into the trial
* Previously married women who have moved into the study area
* Single women (never married, widowers)
* Women who are sterilized (or whose husbands are sterilized)
* Menopausal women
D: Inclusion Criteria:

* Gestational age between 12 weeks and 19 weeks, 6 days, inclusive
* Chronic hypertension
* History of preeclampsia/eclampsia
* Attendance at a participating hospital (Recife, Botucatu, Campinas and Porto Alegre, Brazil)

Exclusion Criteria:

* Planned delivery elsewhere.
* Multifetal gestation.
* Allergy to vitamin C or vitamin E.
* Requirement for aspirin or anticoagulant medication.
* Proteinuria ≥ 2+ on dipstick urine test; or proteinuria = 1+ on dipstick and ≥ 300 mg/24 hours.
* Pre-pregnancy diabetes mellitus.
* Known fetal anomaly incompatible with life.
* Prior participation in the study.
* Unwillingness to take the study medication.

Answer: A