7. Why do mothers die?
The major complications that account for nearly 75% of all maternal
deaths are-
• Severe bleeding (mostly bleeding after childbirth)
• Infections (usually after childbirth)
• High blood pressure during pregnancy (pre-eclampsia and
eclampsia)
• Complications from delivery
• Unsafe abortion.
8. Anaemia in Reproductive age group
trend was seen in the prevalence of anaemia among women in the
age of 15-49 years. Out of the 22 states/UTs covered in phase 1 of
NFHS-5, 16 show an increase in anaemia among women.
9. How can we save mothers from dying?
Majority are preventable - Skilled Birth attendants
Severe bleeding - Efficient Mx of PPH, Anaemia prevention & treatment
Infection- safe delivery practices, antibiotics
Pre-eclampsia - Referral to higher centre
Unsafe abortion-prevent unwanted pregnancies,
Social factors for male preference - Society needs to change
HOW?
Identify High risk pregnancy and referral to higher centre
10. Hinderance to accessible healthcare
The main factors that prevent women from receiving or seeking
care during pregnancy and childbirth are:
• Poverty
• Distance to facilities
• Lack of information
• Inadequate and poor quality services
• Cultural beliefs and practices.
• Financial issues
11. For the use of registered medical practitioner only.
High risk pregnancies worldwide
20 million women
have high-risk
pregnancies
More than 800 die
daily from
perinatal
conditions
Percentages of
high-risk
pregnancies
range from 6% to
33%
Situations and
conditions that
constitute high-
risk pregnancy
are varied
Reference: Holness N. High-Risk Pregnancy. Nurs Clin North Am. 2018 Jun;53(2):241-25
12. For the use of registered medical practitioner only.
High risk pregnancy in India
20-30% pregnancies belong
to high risk category
High risk pregnancies are
responsible for 75% of
perinatal morbidity and
mortality
Reference: Jaideep KC, Prashant D, Girija A. Int J Community Med Public Health 2017;4:1257-9
13. For the use of registered medical practitioner only.
Defining a high-risk pregnancy
Any unexpected or unanticipated medical or obstetric condition
associated with pregnancy with an actual or potential hazard to
the health or well-being of the mother or fetus
Reference: Holness N. High-Risk Pregnancy. Nurs Clin North Am. 2018 Jun;53(2):241-25
14. For the use of registered medical practitioner only.
Classification of high risk
pregnancies
15. For the use of registered medical practitioner only.
Risk Factors for High-risk Pregnancy
Genetic
Nutritional
General
health
status
Medical
disorders
Obstetric
disorders
Biological
Maternal
behaviors
Lifestyle
Emotional
disorders,
Disturbed
interpersonal
relationships
Inadequate
social
support
Unsafe
cultural
practices
Psychological
Lack prenatal
care
Low income,
Sociodemo
graphic
Hazards in
workplace
General
environment
hazards
Chemicals,
gases,
radiation
Environm
ental
Reference: Holness N. High-Risk Pregnancy. Nurs Clin North Am. 2018
Jun;53(2):241-25
16. For the use of registered medical practitioner only.
High risk pregnancy categories
- National Institutes of Health, US
Existing health
conditions
Hypertensive disorders, polycystic ovarian syndrome, diabetes, renal disease,
autoimmune disease, thyroid disease, infertility, obesity, HIV/AIDS
Age Adolescent
First-time pregnancy after 35 y of age
Lifestyle factors Alcohol use
Tobacco use
Illicit drug use
Conditions of pregnancy Multiple gestation
Gestational diabetes
Preeclampsia and eclampsia
Reference: Holness N. High-Risk Pregnancy. Nurs Clin North Am. 2018 Jun;53(2):241-25
17. For the use of registered medical practitioner only.
Pregnancy related medical complications
Women at increased risk of developing similar complications in future pregnancies
Preterm labor, placental abruption, preeclampsia, and gestational diabetes
Reference: Neiger, R J. Clin. Med. 2017, 6, 76;
18. For the use of registered medical practitioner only.
Long term complications for the mother
Gestational
diabetes
Women who had prior
GDM have a 36–70%
risk of developing type 2
DM later in life
At increased risk of
future metabolic
syndrome,
Increased the risk of
cardiovascular disease
Pre-
eclampsia
increased lifetime risk of
chronic hypertension,
cardiovascular disease
(CVD), and stroke
Preterm
Deliveries
At increased risk of
long-term
cardiovascular disease
(CVD) and additional
morbidities
Obstetric
complications
increased risk of long-
term maternal morbidity
including CV mortality
Reference: Neiger, R J. Clin. Med. 2017, 6, 76;
19. For the use of registered medical practitioner only.
High risk pregnancy score
20. For the use of registered medical practitioner only.
High risk pregnancy assessment score
Pre-existing
CV and renal
disorders
Metabolic
disorders
Obstetric
history
Anatomic
anomalies
Other
disorders
Antepartum
Exposure to
teratogens
Pregnancy
complications
Intrapartum
Maternal
Placental
Fetal
Reference: American College of Obstetricians and Gynecologists: Levels of maternal care: Obstetric care consensus No. 9. Obstet Gynecol 134(2):428-434, 2019
High-risk pregnancies require close
monitoring through the pregnancy
especially if women have complex
high-risk conditions
21. High Risk Pregnancy
Score
Dutta S and Das KS 1990.
Identification of high risk
pregnancy by a simple scoring
system J Obstet Gynecol India
37:639-642.
22. For the use of registered medical practitioner only.
Intrapartum assessment
scores
Maternal
Placental Fetal
* A score of 10 or more indicates a high risk.
Reference: American College of Obstetricians and Gynecologists: Levels of maternal care: Obstetric care consensus No. 9. Obstet Gynecol 134(2):428-
434, 2019
23. For the use of registered medical practitioner only.
Modified Coopland
Score
International Journal
of Reproduction,
Contraception,
Obstetrics and
Gynecology
Pillai SS et al. Int J
Reprod Contracept
Obstet Gynecol. 2021
Apr;10(4):1608-1613
www.ijrcog.org
24. For the use of registered medical practitioner only.
SMFM Obstetric care consensus 2019
25. For the use of registered medical practitioner only.
Obstetrics Levels of Care
• Neonatal mortality significantly lower in VLBW neonates born in level 3
NICU as compared to born outside such setup (23% Vs 38%)
• Women with a high comorbidity index had a significantly higher adjusted
relative risk of severe maternal morbidity when they gave birth in hospitals of
low acuity (adjusted OR, 9.55; 95% CI, 6.83e13.35) compared with hospitals
of high acuity (adjusted OR, 6.50; 95% CI, 5.94-7.09)
• Recent data suggest that hospital delivery volume, health care provider
patient volume, and hospital level or rating can all affect maternal outcomes
26. For the use of registered medical practitioner only.
Levels of Maternal Care Obstetric Care Consensus
• Accredited birth centres
• Basic care (level I),
• Specialty care (level II),
• Subspecialty care (level III),
• Regional perinatal health care centers (level IV)
27. For the use of registered medical practitioner only.
Levels of maternal care: definitions, capabilities,
and health care providers*
28. For the use of registered medical practitioner only.
Levels of maternal care: definitions, capabilities,
and health care providers* - Level 1 Basic care
29. For the use of registered medical practitioner only.
Levels of maternal care: definitions, capabilities,
and health care providers* - Level 1 Basic care
30. For the use of registered medical practitioner only.
Levels of maternal care: definitions, capabilities,
and health care providers* - Level 2 Speciality
care
31. For the use of registered medical practitioner only.
Levels of maternal care: definitions, capabilities,
and health care providers* - Level 3 Subspeciality
care
32. For the use of registered medical practitioner only.
Levels of maternal care: definitions, capabilities,
and health care providers* - Level 3 Subspeciality
care
33. For the use of registered medical practitioner only.
Levels of maternal care: definitions, capabilities,
and health care providers* - Level 4 Regional
Perinatal health care centres
34. For the use of registered medical practitioner only.
Levels of maternal care: definitions, capabilities,
and health care providers* - Level 4 Regional
Perinatal health care centres
35. For the use of registered medical practitioner only.
Summary and Recommendations for Obstetric
care
36. For the use of registered medical practitioner only.
Dydrogesterone in High risk Pregnancy
37. For the use of registered medical practitioner only.
Dydrogesterone has a unique
structure that results in
enhanced oral bioavailability of
28% - 5.6 times greater
than oral MCP.1,2
Greater
Bioavailability
Negligible Adverse
Effects
Dydrogesterone minimizes the
activation of receptors other
than progesterone receptor,
and thus minimizes unwanted
effects.1,3
Effective at
Lower Dose
Dydrogesterone causes
endometrial transformation at a
dose 10–20 times lower than that
of micronized progesterone –
only 10 mg2,3
1
2
5
References: 1. Schindler AE, et al. Maturitas. 2003;46 (Suppl 1):S7–S16. 2. Stanczyk FZ, et al. Endocr Rev. 2013;34(2):171–208. 3. Griesinger G, et al. Reprod Biomed Online. 2019;38(2):249–259.
MCP SR: Micronized progesterone sustained release.
Oral Dydrogesterone: The better option
38. For the use of registered medical practitioner only.
Oral MCP: Metabolites Interfere with Pregnancy Outcomes
Reference: 1. Licciardi FL, et al. Fertil Steril. 1999;71(4):614–8.
1
2
4
5
Lower Implantation
rate
Interference of metabolites with
transcription co-factor or DNA binding
action results in a lower implantation
rate per embryo.1
Detrimental Effects of
Metabolites
High concentration of circulating
metabolites with oral MCP- 5α and
5ß reduced pregnanolones
adversely affect
pregnancy outcome.1
MCP SR: Micronized progesterone sustained release.
No documented evidence available for the immunomodulatory effects of progesterone metabolites.
39. For the use of registered medical practitioner only.
DHD shifts cytokine balance towards
Th2 cytokine production that is
conducive to the success of
pregnancy.1
Major Metabolite Supports
Pregnancy
DHD induces NO synthesis that
improves the endometrial
receptivity and pregnancy
outcomes.1,2
Improved Endometrial
Receptivity
1
2
4
5
Th: T helper; NO: Nitric oxide; DHD: Dihydrodydrogesterone.
References: 1. Raghupathy R, et al. Am J Reprod Immunol. 2015;74(5):419–426. 2. Abdel-Razik M, et al. J Reprod Infertil.
Oral Dydrogesterone: Metabolites Action
Conducive to Successful Pregnancy
40. For the use of registered medical practitioner only.
Oral Dydrogesterone: Backed by Evidence
Bioavailability
Approved in Pregnancy Indications?
Global Availability
Documented Evidence of Immunomodulation?
Adverse Effects?
Pregnancy Outcomes?
Effect of Metabolites?
Dydrogesterone Oral MCP SR
Approved in TM, RPL, LPD and other
progesterone deficiencies1
Approved only for secondary
amenorrhea2
Available in 115 countries3 Available in India only3
28% bioavailability5 <5% bioavailability6
Minimizes unwanted effects &
activation of other unwanted receptors6
Metabolites can cause dizziness
& drowsiness7
Major metabolite DHD* conducive to
success of pregnancy8
Major metabolites may adversely
affect pregnancy outcomes7
DHD* induced NO synthesis improves
endometrial receptivity & pregnancy
outcomes9
Major metabolites may affect
normal progesterone action7
Documented trials 8,10,11,12,13 Zero published pubmed indexed
clinical trials14
41. Data on file.
API: Active pharmaceutical ingredient.
*Contains and error for triene determination (The wrong relative response factor for triene and the wrong concentration of the reference solution for triene).
**Specification is under review by European Pharmacopoeia committee to reduce impurities level to 0.015. Proposal approved Netherlands and is under review by EDQM (EU central decision).
Permissible limits of 6-dehydroprogesterone
Abbott’s Dydrogesterone– dydrogesterone is manufactured with stringent quality standards at
one global facility – Abbott’s Weesp facility in the Netherlands.
Indian
pharmacopoeia*
European
pharmacopoeia**
Dydrogesterone Abbotts
quality standards
≤ 0.20%
Permitted limit
≤ 0.15%
Permitted limit
≤ 0.05%
Below limit of
quantification
Abbott’s Dydrogesterone is
Manufactured with Stringent Quality Standards
42. For the use of registered medical practitioner only.
Key Takeaways
43. For the use of registered medical practitioner only.
Key Takeaways
Any condition
associated with a
pregnancy with an
actual or potential
hazard to the
wellbeing
of the mother or fetus
is considered a high-
risk pregnancy.
.
Careful risk
assessment and
individualized care are
needed for each
pregnancy
Maternal-fetal
assessment tools help
determine the risk
ART: Assisted reproductive technique.
The situations and
conditions that
create high-risk
pregnancy status
are varied.
.
44. For the use of registered medical practitioner only.
Key Takeaways
Progesterone
deficiency leads to
inadequate
immunoregulation
that subsequently
results in miscarriage
Oral dydrogesterone
40-mg stat dose
followed maintenance
dose was found to be
more effective than
conservative therapy
in the treatment of
threatened
miscarriage
.
Oral dydrogesterone
20 mg (10-mg twice
daily) till 20 weeks of
pregnancy is indicated
for the treatment of
recurrent miscarriage
Oral dydrogesterone is
the best option for
luteal phase support in
women undergoing
ART treatment
ART: Assisted reproductive technique.
45. For the use of registered medical practitioner only.
Thank You!
