Alkem

Subject Initials *

Investigator *

Centre *

Date of Assessment *

Age (in Years) *

Height (in cm) *

Weight *

a) first antenatal visit (kg)

b) last antenatal visit

Obstetric History *

G(Gravida)

P(Para)

A(Abortus)

L(Living)

Obstetrics history for any associated comorbidities *

Pregnancy induced hypertension Gestational diabetes mellitus Anemia of pregnancy Others

Gestational Age (weeks) *

Amniotic fluid index at 3rd trimester (if available)

BMI at first and last antenatal visit (if available)

First

Last

Brand Name *

Marketing Company Name*

Dose *

Frequency*

Duration *

Duration Amino acid supplementation was given in which trimester of pregnancy? *

1st Trimester 2nd Trimester 3rd Trimester

Primary reason for prescribing Amino acid supplementation *

Prophylactic Therapeutic

If therapeutic then for which reason supplementation was given? (if available)

IUGR (Intra uterine growth restriction) Oligohydramnios Hyperemesis Gravidarum Others

Other medications prescribed for T/t

Medication	Dose	Frequency	Duration	Trimester	Indication

Concomitant Diseas	Duration of Disease	Medication	Dose	Frequency

Pregnancy outcome (after supplementation)? (Multiple options can be clicked) (if available)

Normal healthy baby Low birth weight baby Pre-term baby Still birth Others

Birth weight of the baby (kg)

APGAR Score (if available)

1 Min

5 Min

Adverse events noted due to study medication *

Yes No

ADVERSE EVENT(S)
AE. No	Adverse Event Term	Date of onset (DD/MM/YYYY)	Severity	Action Taken	Treatment given	Relationship with Study Drug	Outcome	Serious Adverse Event
1					Yes No			Yes No
2					Yes No			Yes No
3					Yes No			Yes No
4					Yes No			Yes No
Severity: 1- Mild; 2- Moderate; 3- Severe; +Action Taken: 1- No Change in IP, 2- IP Temporarily Interrupted, 3- IP Permanently Discontinued, 4- Other, specify *If 'Treatment given 'is ticked as 'Yes' then relevant information should be captured on Prior and concomitant Medication Form. Relationship: 1= Related, 2= Not Related ++Outcome: 1 = Resolved, 2= Recovered/ Resolved with Sequelae, 3= Recovering/ Resolving, 4=Not Recovered/ Not Resolved, 5= Fatal/ result in death, 6= Unknown

Amino acid Clean

ASSESSMENT OF THERAPY PRESCRIBED

DEMOGRAPHICS and ANTHROPOMETRY

OBSTETRIC HISTORY AND MATERNAL HEALTH PROFILE

DETAILS OF MEDICATION USED DURING PREGNANCY

CONCOMITANT DISEASE and MEDICATION

PREGNANCY OUTCOME

ADVERSE EVENTS