OBJECTIVE: To compare preterm birth rate and neonatal outcome in twin gestations randomized to either 17 alpha-hydroxyprogesterone caproate (17P) or placebo. MATERIALS AND METHODS:Women with twin gestations between 20-30 weeks were randomized to receive weekly injections of either 250 mg 17P injection (Group I), or placebo (Group II). Maternal and neonatal outcome data was recorded. RESULTS:Thirty twin intrauterine pregnancies were randomized; 16 received 17P and 14 received placebo. Demographic data as well as past history and gestational age at randomization were equivalent between groups (P = 0.286-0.847). All patients in both groups were Medicaid recipients. The incidence of preterm labor (P = 0.980), and premature rupture of the membranes (P = 0.525) were the same between groups. Gestational age at delivery was also similar between 17P (33.9 weeks) versus placebo (33.1 weeks, P = 0.190) as was the incidence of preterm birth <35 weeks (44% vs 79%, P = 0.117). Infant weight (P = 0.641), Apgar score at 5 minutes (P = 0.338) as well as neonatal morbidity such as respiratory distress syndrome (P = 0.838), patent ductus arteriosus (P = 0.704), intraventricular hemorrhage (P = 0.851) and necrotizing enterocolitis (P = 0.946) showed no difference. Days spent in the NICU among 17P (18.4) versus placebo (17.3, P = 0.155), neonatal death (P = 0.359) and those infants discharged with neurologic handicap (P = 0.594) were not different between groups. CONCLUSION: Amongst this group of twin gestations weekly 17HP injections did not reduce the incidence of preterm birth or the complications associated with prematurity.
RCT Entities:
OBJECTIVE: To compare preterm birth rate and neonatal outcome in twin gestations randomized to either 17 alpha-hydroxyprogesterone caproate (17P) or placebo. MATERIALS AND METHODS:Women with twin gestations between 20-30 weeks were randomized to receive weekly injections of either 250 mg 17P injection (Group I), or placebo (Group II). Maternal and neonatal outcome data was recorded. RESULTS: Thirty twin intrauterine pregnancies were randomized; 16 received 17P and 14 received placebo. Demographic data as well as past history and gestational age at randomization were equivalent between groups (P = 0.286-0.847). All patients in both groups were Medicaid recipients. The incidence of preterm labor (P = 0.980), and premature rupture of the membranes (P = 0.525) were the same between groups. Gestational age at delivery was also similar between 17P (33.9 weeks) versus placebo (33.1 weeks, P = 0.190) as was the incidence of preterm birth <35 weeks (44% vs 79%, P = 0.117). Infant weight (P = 0.641), Apgar score at 5 minutes (P = 0.338) as well as neonatal morbidity such as respiratory distress syndrome (P = 0.838), patent ductus arteriosus (P = 0.704), intraventricular hemorrhage (P = 0.851) and necrotizing enterocolitis (P = 0.946) showed no difference. Days spent in the NICU among 17P (18.4) versus placebo (17.3, P = 0.155), neonatal death (P = 0.359) and those infants discharged with neurologic handicap (P = 0.594) were not different between groups. CONCLUSION: Amongst this group of twin gestations weekly 17HP injections did not reduce the incidence of preterm birth or the complications associated with prematurity.
Authors: Roberto Romero; Kypros Nicolaides; Agustin Conde-Agudelo; Ann Tabor; John M O'Brien; Elcin Cetingoz; Eduardo Da Fonseca; George W Creasy; Katharina Klein; Line Rode; Priya Soma-Pillay; Shalini Fusey; Cetin Cam; Zarko Alfirevic; Sonia S Hassan Journal: Am J Obstet Gynecol Date: 2011-12-11 Impact factor: 8.661
Authors: C A Combs; E Schuit; S N Caritis; A C Lim; T J Garite; K Maurel; D Rouse; E Thom; A T Tita; Bwj Mol Journal: BJOG Date: 2015-12-10 Impact factor: 6.531
Authors: E Schuit; S Stock; L Rode; D J Rouse; A C Lim; J E Norman; A H Nassar; V Serra; C A Combs; C Vayssiere; M M Aboulghar; S Wood; E Çetingöz; C M Briery; E B Fonseca; K Worda; A Tabor; E A Thom; S N Caritis; J Awwad; I M Usta; A Perales; J Meseguer; K Maurel; T Garite; M A Aboulghar; Y M Amin; S Ross; C Cam; A Karateke; J C Morrison; E F Magann; K H Nicolaides; N P A Zuithoff; R H H Groenwold; K G M Moons; A Kwee; B W J Mol Journal: BJOG Date: 2014-08-22 Impact factor: 6.531
Authors: Ewoud Schuit; Sarah Stock; Rolf H H Groenwold; Kimberly Maurel; C Andrew Combs; Thomas Garite; Cathy Y Spong; Elizabeth A Thom; Dwight J Rouse; Steve N Caritis; George R Saade; Julia M Zachary; Jane E Norman; Line Rode; Katharina Klein; Ann Tabor; Elçin Cetingöz; John C Morrison; Everett F Magann; Christian M Briery; Vicente Serra; Alfredo Perales; Juan Meseguer; Anwar H Nassar; Arianne C Lim; Karel G M Moons; Anneke Kwee; Ben Willem J Mol Journal: BMC Pregnancy Childbirth Date: 2012-03-15 Impact factor: 3.007
Authors: Fiona Cheong-See; Ewoud Schuit; David Arroyo-Manzano; Asma Khalil; Jon Barrett; K S Joseph; Elizabeth Asztalos; Karien Hack; Liesbeth Lewi; Arianne Lim; Sophie Liem; Jane E Norman; John Morrison; C Andrew Combs; Thomas J Garite; Kimberly Maurel; Vicente Serra; Alfredo Perales; Line Rode; Katharina Worda; Anwar Nassar; Mona Aboulghar; Dwight Rouse; Elizabeth Thom; Fionnuala Breathnach; Soichiro Nakayama; Francesca Maria Russo; Julian N Robinson; Jodie M Dodd; Roger B Newman; Sohinee Bhattacharya; Selphee Tang; Ben Willem J Mol; Javier Zamora; Basky Thilaganathan; Shakila Thangaratinam Journal: BMJ Date: 2016-09-06