Effectiveness of different Prescription Method of Vitamin D3 on Obstetric and Early Neonatal Outcomes in Pregnant Women with Vitamin D deficiency

Effectiveness of different Prescription Method of Vitamin D3 on Obstetric and Early Neonatal Outcomes in Pregnant Women with Vitamin D deficiency

In the second phase of the study, to assess the effect of screening strategy on maternal and neonatal outcomes, Masjed-Soleyman participants were assigned to a screening program versus Shushtar participants acting as the nonscreening arm. Within the framework of the screening regimen, an 8-arm blind randomized clinical trial was undertaken to compare the effects of various treatment protocols. Due to the cost and complexity of the process, 800 pregnant women with vitamin D deficiency from Masjed-Soleyman were randomly allocated to 1 of the designed intervention programs. The remaining women with vitamin D deficiency were referred to specialists for further treatments. Participants of Shushtar did not receive any vitamin D supplementation. However, the comparison of the basic confounders between the initial recruited sample in Masjed-Soleyman and the women allocated to intervention indicated no statistically significant difference and hence no selection bias occurred during the allocation of treatment. Women with severe vitamin D deficiency (Group A) Group A1: Subjects were treated with 50,000 IU of oral vitD3 weekly for a total duration of 12 weeks. Group A2: Subjects were treated with 50,000 IU of oral vitD3 weekly for a total duration of 12 weeks and then were on monthly maintenance dose of 50,000 IU vitD3 until delivery. Group A3: Subjects were treated with intramuscular administration of 300,000 IU vitD3; 2 doses for 6 weeks. Group A4: Subjects were treated with Intramuscular administration of 300,000 IU vitD3; 2 doses for 6 weeks and then were on monthly maintenance dose of 50,000 IU vitD3 until delivery. Women with moderate vitamin D deficiency (Group B) Group B1: Subjects were treated with 50,000 IU oral vitD3 weekly for a total duration of 6 weeks. Group B2: Subjects were treated with 50,000 IU oral vitD3 weekly for a total duration of 6 weeks and then were on monthly maintenance dose of 50,000 IU vitD3 until delivery. Group B3: Subjects were treated with a single dose of intramuscular administration of 300,000 IU vitD3. Group B4: Subjects were treated with a single dose of Intramuscular administration of 300,000 IU vitD3 and then were on monthly maintenance dose of 50,000 IU vitD3 until delivery.

Using the cluster sampling method, 1600 and 900 first trimester mothers were selected from among those receiving prenatal care in health centers in urban regions of Masjed-Soleyman and Shushtar, respectively. Subjects in each group of severe or moderate deficiencies were randomly divided into 4 subgroups using permuted block randomization by a biostatistician to achieve balance across treatment groups. The number of subjects per block was 8. Sealed opaque envelopes were assigned to each subject by a research assistant not associated in the trial. The dedicated study midwife treating the females, who did not participate in any subsequent phases of the study, was the only person who knew the group each patient belonged to (single blinded). Masking to treatment allocation was not possible and only those health care workers who determined pregnancy outcomes were blinded to treatment allocation.

Pregnant women, aged 18-40 years, were eligible if they had gestational age <14 weeks based on last menstrual period or obstetrical estimation, singleton pregnancy, and had planned to receive ongoing prenatal and delivery in the Masjed-Soleiman. Participants were excluded if they consumed multivitamins containing more than 400 international unit (IU) per day of vitamin D3; used anticonvulsants; and had history of chronic diseases like diabetes, hypertension, renal dysfunction, liver diseases, and complicated medical or obstetrical history.

Women with severe vitamin D deficiency (Group A) Group A1: Subjects were treated with 50,000 IU of oral vitD3 weekly for a total duration of 12 weeks. Group A2: Subjects were treated with 50,000 IU of oral vitD3 weekly for a total duration of 12 weeks and then were on monthly maintenance dose of 50,000 IU vitD3 until delivery. Group A3: Subjects were treated with intramuscular administration of 300,000 IU vitD3; 2 doses for 6 weeks. Group A4: Subjects were treated with Intramuscular administration of 300,000 IU vitD3; 2 doses for 6 weeks and then were on monthly maintenance dose of 50,000 IU vitD3 until delivery. Women with moderate vitamin D deficiency (Group B) Group B1: Subjects were treated with 50,000 IU oral vitD3 weekly for a total duration of 6 weeks. Group B2: Subjects were treated with 50,000 IU oral vitD3 weekly for a total duration of 6 weeks and then were on monthly maintenance dose of 50,000 IU vitD3 until delivery. Group B3: Subjects were treated with a single dose of intramuscular administration of 300,000 IU vitD3. Group B4: Subjects were treated with a single dose of Intramuscular administration of 300,000 IU vitD3 and then were on monthly maintenance dose of 50,000 IU vitD3 until delivery.

Primary endpoints are to find out the beneficiary impact of screening of pregnant women for vitamin D deficiency on pregnancy and neonatal outcomes and assessing the effect of supplementation with vitamin D on these outcomes.

Endocrine Research Center Shahid Beheshti University of Medical Sciences

Subjects in each group of severe or moderate deficiencies were randomly divided into 4 subgroups using permuted block randomization by a biostatistician to achieve balance across treatment groups. The number of subjects per block was 8. Sealed opaque envelopes were assigned to each subject by a research assistant not associated in the trial.

The dedicated study midwife treating the females, who did not participate in any subsequent phases of the study, was the only person who knew the group each patient belonged to (single blinded). Masking to treatment allocation was not possible and only those health care workers who determined pregnancy outcomes were blinded to treatment allocation.

Yet not decided.

Yet not decided.

Yet not decided.

Yet not decided.

Yet not decided.

Yet not decided.