What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth

Caritis, Steve N.; Feghali, Maisa; Grobman, William A.; Rouse, Dwight J.

doi:10.1053/j.semperi.2016.03.002

Cited by 7 publications

(2 citation statements)

References 50 publications

(56 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Initial studies suggested a potential benefit for 17-alpha-hydroxyprogesterone caproate (17-OHPC) in decreasing the risk of recurrent preterm birth women with a singleton gestation. However, the use of 17-OHPC has not conferred benefit for other categories of women at high risk for preterm delivery (twins, triplets, and short cervical length) [26]. In this study, patient satisfaction with its use was significantly better than oral progesterone despite injection site problems in 20% of cases.…”

Section: Discussionmentioning

confidence: 56%

Oral Micronized or Parenteral Progesterone versus Health Education in the Prevention of Preterm Birth: A Single Blinded Randomized Controlled Trial

Darwish¹,

Ismail²,

Mohammad³

et al. 2019

OJOG

View full text Add to dashboard Cite

Objective: The primary aim of this study was to evaluate the possible prophylactic role of progesterone in women with a history of spontaneous preterm birth (PTB) while the secondary aim was to compare oral or intramuscular progesterone versus health education in such cases. Methods: A randomized, single blinded interventional randomized controlled trial was conducted. It comprised 90 cases with a history of PTB who were divided into 3 equal groups who received oral micronized progestogen capsule 200 mg daily (group A), parenteral 17 α-hydroxyprogesterone caproate 250 mg weekly IM injections (group B) or received health education including rest (group C) starting from 20 weeks till the end of 34 weeks of gestation. Results: This study included eligible 90 pregnant women at high risk of PTB who continued follow-up. For socio-demographic characteristics, there were no significant differences between the groups in respect to age, residence, education level, occupation, gravidity, parity and number of living children apart from significant difference between group A and C regarding mean patients' age. Mode and place of delivery did not differ between the groups while gestational age at time of delivery was significantly better on using injectable than oral progesterone. Neonatal birth weight was significantly higher in group B if compared separately to groups A and C and was still significantly higher in group A if compared with group C. NICU admission rate was higher in group C if compared to group B or to the combined group A and B. Compliance was significantly higher in group B if compared to both group A and C and was significantly higher in the intervention group A and B if compared to group C. Conclusions: Progesterone supplementation has a significant role in prevention of PTB if compared with just health education.

show abstract

Section: Discussionmentioning

confidence: 56%

Oral Micronized or Parenteral Progesterone versus Health Education in the Prevention of Preterm Birth: A Single Blinded Randomized Controlled Trial

Darwish¹,

Ismail²,

Mohammad³

et al. 2019

OJOG

View full text Add to dashboard Cite

show abstract

“…Sterile compounding involves a great deal of risk compared to product manufacturing by a pharmaceutical company. In spite of the enforcement of USP <797> by the FDA, there are plenty of cases reported where poor compounding practice or compounding error resulted in severe consequences or deaths [7,35]. Very recently AMAG pharmaceuticals has introduced a single-dose generic version of preservative-free Makena ® to circumvent such issues.…”

Section: Discussionmentioning

confidence: 99%

17-α Hydroxyprogesterone Nanoemulsifying Preconcentrate-Loaded Vaginal Tablet: A Novel Non-Invasive Approach for the Prevention of Preterm Birth

et al. 2019

View full text Add to dashboard Cite

Preterm birth (PTB) is a major cause of infant mortality in the United States and around the globe. Makena®—once-a-week intramuscular injection of 17-α Hydroxyprogesterone caproate (17P)—is the only FDA approved treatment for the prevention of PTB. Invasive delivery of 17P requires hospitalization and expert personnel for injection. Vaginal delivery of 17P would be preferable, because of high patient compliance, reduced systemic exposure, fewer side effects, and no need for hospitalization. The objective of the present study was to prepare and evaluate a self-nanoemulsifying vaginal tablet of 17P. A solid self-nanoemulsifying preconcentrate (S-SNEDDS) of 17P and dimethylacetamide (DMA) was developed using medium chain triglycerides, a non- immunogenic surfactant, and co-processed excipient (PVA-F100). The tablet prepared was characterized for emulsification time, particle size, solid state properties, and drug release. The formulation showed >50% inhibition of TNF-α release from LPS-stimulated RAW 264.7 cells. Importantly, there were significant differences in rates of PTB and average time to delivery between control and vaginal 17P-treated groups in LPS-stimulated timed pregnant E15.5 mice. Considering the lacuna of therapeutic approaches in this area, vaginal delivery of 17P for the prevention of preterm birth has significant clinical relevance.

show abstract

Pharmacokinetics and tolerability of a novel progesterone intravaginal ring in sheep

Weiss¹,

Martell

Constantine³

et al. 2019

Drug Deliv. and Transl. Res.

View full text Add to dashboard Cite

What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth

Cited by 7 publications

References 50 publications

Oral Micronized or Parenteral Progesterone versus Health Education in the Prevention of Preterm Birth: A Single Blinded Randomized Controlled Trial

Oral Micronized or Parenteral Progesterone versus Health Education in the Prevention of Preterm Birth: A Single Blinded Randomized Controlled Trial

17-α Hydroxyprogesterone Nanoemulsifying Preconcentrate-Loaded Vaginal Tablet: A Novel Non-Invasive Approach for the Prevention of Preterm Birth

Pharmacokinetics and tolerability of a novel progesterone intravaginal ring in sheep

Contact Info

Product

Resources

About